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Element 47 Face and Body Acne Treatment

Medically reviewed on April 10, 2018.

Dosage form: spray
Ingredients: SALICYLIC ACID 5mg in 1mL
Labeler: Worldceuticals, LLC
NDC Code: 69753-002

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.

Element 47 Face and Body Acne Treatment

Active Ingredient

Salicylic Acid (0.5%)

Purpose

Acne Treatment

Uses

• For the treatment of acne. • Penetrates pores to help control acne blemishes

Warnings

• For external use only.

When using this product

• Avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.

• Using other topical acne medications at the same time or immediately following use of this product may increase

dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Keep out of the reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Cleanse the skin thoroughly before applying

• For chest and back, spray on affected areas one to three times daily. For face, apply with a cotton ball to entire face one to three times daily.

• 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

Sensitivity for a new user: Apply product sparingly to one or two small affected areas during the first 3 days. If no

discomfort occurs, follow the directions stated above.

Inactive Ingredients

• Aqua (Water), Propanediol, CoTcamidopropyl Betaine, Aloe

Barbadensis Leaf Juice, Colloidal Silver (preservative)*, Tocopheryl Acetate, Glycerin, Allantoin, Citrus

Grandis (Grapefruit) Fruit Extract, Lauryl Glucoside, Tetrasodium EDTA, PEG/PPG-4/12 Dimethicone,

Sodium Benzoate, Potassium Sorbate, Diazolidinyl Urea, Sodium Hydroxide (*Less than 1%)

Questions?

844-269-7296 www.Element47Skincare.com

Product Labeling

ELEMENT 47

FACE & BODY

ACNE TREATMENT

FACE & BODY

ACNE TREATMENT

FORMULATED FOR

SENSITIVE SKIN TYPES

8 FL. OZ. (240ML)

ELEMENT 47 FACE AND BODY ACNE TREATMENT 
salicylic acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69753-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPANEDIOL 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE 
GLYCERIN 
ALLANTOIN 
PUMMELO 
LAURYL GLUCOSIDE 
EDETATE SODIUM 
PEG/PPG-4/12 DIMETHICONE 
SODIUM BENZOATE 
POTASSIUM SORBATE 
DIAZOLIDINYL UREA 
Packaging
#Item CodePackage Description
1NDC:69753-002-001 BOTTLE, SPRAY in 1 CARTON
1240 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/10/2015
Labeler - Worldceuticals, LLC (079782424)
Establishment
NameAddressID/FEIOperations
Avadim Technologies, Inc.041443877manufacture(69753-002)

 
Worldceuticals, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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