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BeyondClear

Generic Name: salicylic acid and benzoyl peroxide
Dosage Form: topical kit

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

BeyondClear Skin Clearing System

Chemical Structure

Benzoyl Peroxide

Salicylic Acid

Active ingredient                                                                 

Benzoyl Peroxide 4.25%

Salicylic Acid (2.0%) 

Purpose

Acne medication

Uses

For the treatment of breakouts or acne

Warnings

For external use only. Do not use if
  • you have very sensitive skin 
  • are sensitive to benzoyl peroxide

When using this product

For Pure

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time unless directed by a doctor
  • Avoid contact with the eyes. If contact occurs, immediately flush with water.

For Clear 

  • skin irritation and dryness is more likely to occur if use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently, in smaller amount or in a lower concentration.

Stop use and ask a doctor if skin irritation becomes severe

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For Pure

Use in the morning and evening. Put a nickel- sized amount in hand

  • Cover the entire area of concern with a thin layer Gently massage on to wet skin. Rinse and pat dry 
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

For Clear

Use in the morning and evening after cleansing 

  • Clean the skin thoroughly before applying this product
  • Cover the entire area of concern with a thin layer two times daily. Hold can upright. Dispense a dime-sized amount of product in your hand. Gently massage into skin. No need to shake container. Store upright
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

For FAST

  • Clean the skin thoroughly before applying this product. Use as needed and on-the-go
  • Apply a thin layer directly on the breakout area. Start with one application daily, and increase to two if needed. Do not rinse off
  • If bothersome dryness occurs, reduce usage
  • Sun protection is recommended by dermatologists as an essential part of any healthy skin care regimen.

Inactive Ingredients

For Pure

Purified Water, Glycerin, PEG-120 Methyl Glucose Dioleate, Cocamidopropyl Betaine, Sodium Cocoamphoacetate, PEG-200 Hydrogenated Glyceryl Palmate, Glucoside, Disodium Cocoyl Glutamate, Xylitylglucoside, Sodium Cocoyl Glutamate, Sodium Lauryl Glucose Carboxylate, Acer Saccharum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Vaccinium Myrtillus Fruit/Leaf Extract, Anhydroxylitol, Lappa Root Extract, Citrus Limon (Lemon) Extract, Glycolic Acid, Hydroxyphenyl Propamidobenzoic Acid, Mandelic Acid, Sisymbrium Officinale Extract, Xylitol, Zinc PCA, PEG-7 Glyceryl Cocoate, Pentylene Glycol, Benzyl Alcohol, Butylene Glycol, Citric Acid, Sclerotium Gum, Fragrance, Polysorbate 20.

For Clear

Water, Hydrofluorocarbon 227ea, Glycerin, Pentylene Glycol, Emulsifying Wax, Dimethicone, Chamomilla Recutita (Matricaria) Flower Extract, Symphytum Officinale Extract, Phenoxyetha- nol, Steareth-10, C12-15 Alkyl Benzoate, Sodium Citrate, Cetearyl Alcohol, Fragrance, Disodium EDTA, BHT, Citric Acid, Aloe Barbadensis Leaf Juice.

For FAST

Purified Water, SD Alcohol 40-B, Butylene Glycol, Lactobacillus/Wasabia Japonica Root Ferment Extract, Glycerin, Polyacrylate Crosspolymer- 6, Allantoin, Bisabolol, Epilobium Fleischeri Extract, Juglans Nigra (Black Walnut) Shell Extract, Spiraea Ulmaria Extract, Hydroxyphenyl Propamidobenzoic Acid, Disodium EDTA, Pentylene Glycol, Ethylhexylglycerin, Phenoxyethanol.

Other Information Store at room temperature 59º-77ºF (15º-25ºC).

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - PURE PURIFYING CLEANSER Label

NDC 24424-248-96

CLARIFOAMTM

1 PURE
   PURIFYING
   CLEANSER

2% Salicylic Acid
Clears Acne

Professional
Skin Clearing
System

125 mL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - CLEAR CLARIFYING TREATMENT Label

NDC 24424-328-50

CLARIFOAMTM

2 CLEAR
   CLARIFYING
   TREATMENT

4.25% Benzoyl Peroxide
Clears Acne

Professional
Skin Clearing
System

50g

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - FAST SPOT CLEARING ACCELERATOR Label

NDC 24424-246-07

CLARIFOAMTM

FAST
SPOT
CLEARING
ACCELERATOR

2% Salicylic Acid
Clears Acne

Professional
Skin Clearing
System

7 mL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - BeyondClear Skin Clearing System Kit Label

NDC 24424-351-00

BeyondClearTM

Skin Clearing System

with Clarifoam TechnologyTM

Established Pharmacological Class
Substance Pharmacological Class
Healthy Cleansing (cold creams, cleansing lotions, liquids, and pads)
Boost Cleansing (cold creams, cleansing lotions, liquids, and pads)
BeyondClear 
salicylic acid and benzoyl peroxide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24424-351
Packaging
# Item Code Package Description
1 NDC:24424-351-00 1 KIT in 1 BOX
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 125 mL
Part 2 1 CAN 50 g
Part 3 1 TUBE 7 mL
Part 4 1 BOTTLE 50 mL
Part 5 1 TUBE 15 mL
Part 1 of 5
PURE 
salicylic acid gel
Product Information
Item Code (Source) NDC:24424-248    
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2.232 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
COCAMIDOPROPYL BETAINE  
PEG-120 METHYL GLUCOSE DIOLEATE  
LAURYL GLUCOSIDE  
GLYCERYL PALMITATE  
DISODIUM COCOYL GLUTAMATE  
SODIUM COCOYL GLUTAMATE  
XYLITYLGLUCOSIDE  
ACER SACCHARUM BARK/SAP  
CITRUS AURANTIUM FRUIT RIND  
SUGARCANE  
VACCINIUM MYRTILLUS LEAF  
ANHYDROXYLITOL  
ARCTIUM LAPPA ROOT  
CITRUS LIMON FRUIT OIL  
GLYCOLIC ACID  
HYDROXYPHENYL PROPAMIDOBENZOIC ACID  
MANDELIC ACID  
SISYMBRIUM OFFICINALE WHOLE  
XYLITOL  
ZINC PIDOLATE  
PEG-7 GLYCERYL COCOATE  
PENTYLENE GLYCOL  
BENZYL ALCOHOL  
BUTYLENE GLYCOL  
CITRIC ACID MONOHYDRATE  
BETASIZOFIRAN  
POLYSORBATE 20  
Packaging
# Item Code Package Description
1 NDC:24424-248-96 125 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 06/01/2012
Part 2 of 5
CLEAR 
benzoyl peroxide aerosol, foam
Product Information
Item Code (Source) NDC:24424-328    
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 4.25 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
APAFLURANE  
GLYCERIN  
PENTYLENE GLYCOL  
WHITE WAX  
DIMETHICONE  
CHAMOMILE  
COMFREY ROOT  
PHENOXYETHANOL  
STEARETH-10  
ALKYL (C12-15) BENZOATE  
SODIUM CITRATE  
CETOSTEARYL ALCOHOL  
EDETATE DISODIUM  
BUTYLATED HYDROXYTOLUENE  
CITRIC ACID MONOHYDRATE  
ALOE VERA LEAF  
Packaging
# Item Code Package Description
1 NDC:24424-328-50 50 g in 1 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 06/01/2012
Part 3 of 5
FAST 
salicylic acid cream
Product Information
Item Code (Source) NDC:24424-246    
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2.014 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
ALCOHOL  
BUTYLENE GLYCOL  
WASABI ROOT  
GLYCERIN  
ALLANTOIN  
LEVOMENOL  
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP  
JUGLANS NIGRA BARK  
FILIPENDULA ULMARIA ROOT  
HYDROXYPHENYL PROPAMIDOBENZOIC ACID  
EDETATE DISODIUM  
PENTYLENE GLYCOL  
ETHYLHEXYLGLYCERIN  
PHENOXYETHANOL  
Packaging
# Item Code Package Description
1 NDC:24424-246-07 7 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 06/01/2012
Part 4 of 5
HEALTHY 
skin accelerator lotion
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Ingredients
Ingredient Name Quantity
WATER  
NIACINAMIDE  
GLYCERIN  
CETOSTEARYL ALCOHOL  
ISONONYL ISONONANOATE  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)  
MEDIUM-CHAIN TRIGLYCERIDES  
ALLANTOIN  
PANTHENOL  
CAPRYLOYL GLYCINE  
SARCOSINE  
CINNAMON BARK OIL  
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP  
AVENA SATIVA FLOWERING TOP  
LEVOMENOL  
GINGER  
BLACK RASPBERRY  
CRANBERRY SEED OIL  
WATERMELON SEED OIL  
RASPBERRY SEED OIL  
SALVIA HISPANICA SEED  
PUNICA GRANATUM SEED OIL  
PUNICA GRANATUM ROOT BARK  
RETINOL  
TETRAHEXYLDECYL ASCORBATE  
EGG PHOSPHOLIPIDS  
CERAMIDE 3  
CERAMIDE 6 II  
CERAMIDE 1  
PHYTOSPHINGOSINE  
CHOLESTEROL  
CHAMOMILE  
COMFREY LEAF  
SILICON DIOXIDE  
PHENOXYETHANOL  
ETHYLHEXYLGLYCERIN  
CETEARYL GLUCOSIDE  
SODIUM ASCORBATE  
TOCOPHEROL  
VITAMIN A PALMITATE  
.ALPHA.-TOCOPHEROL ACETATE, D-  
ASCORBYL PALMITATE  
SODIUM LAUROYL LACTYLATE  
CARBOMER 1342  
XANTHAN GUM  
GLYCERYL MONOSTEARATE  
PEG-100 STEARATE  
POLYSORBATE 20  
EDETATE SODIUM  
Packaging
# Item Code Package Description
1 50 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 06/01/2012
Part 5 of 5
BOOST 
5 day quick start treatment gel
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Ingredients
Ingredient Name Quantity
WATER  
ALCOHOL  
GLYCERIN  
ARGININE  
PENTYLENE GLYCOL  
GLYCOLIC ACID  
MANDELIC ACID  
LACTIC ACID  
PANTHENOL  
SALICYLIC ACID  
POLYQUATERNIUM-10 (400 CPS AT 2%)  
BROMELAINS  
NIACINAMIDE  
PAPAIN  
ARTEMISIA VULGARIS ROOT  
HYALURONATE SODIUM  
CAMELLIA OLEIFERA LEAF  
PHENOXYETHANOL  
Packaging
# Item Code Package Description
1 15 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 06/01/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 06/01/2012
Labeler - Proskin LLC (969956668)
Registrant - Precision Dermatology, Inc. (056267369)
Establishment
Name Address ID/FEI Operations
Precision Dermatology, Inc. 056267369 MANUFACTURE(24424-351)
Revised: 06/2012
 
Proskin LLC



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