Magic Marker

Dosage form: gel
Ingredients: Benzoyl Peroxide 52.5mg in 1g
Labeler: CoValence Inc.
NDC Code: 66915-436

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.

Drug Facts

Directions
  • Clean Skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer 1 to 3 times daily.
  • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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.
  • Sensitivity Test for a New User; Apply product sparingly to one or two small affected areas during the first 2 days.  If no discomfort occurs, follow the directions stated elsewhere on this label.

Active Ingredient:   Benzoyl Peroxide 5%

Uses

  • for the treatment of acne
  • helps clear up acne blemishes
  • helps prevent new acne blemishes from forming

Warnings

For external use only

When using this product
  • 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.

Do not use if you

  • have very sensitive skin.
  • are sensitive to benzoyl peroxide

When using this product

  • avoid unnecessary skin exposure and use a sunscreen
  • avoid contact with eyes, lips and mouth.  If eye contact accidentally occurs, rinse eyes throughly with water.
  • 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 or in a lower concentration.

Stop use and ask a doctor if irritation becomes severe.

Inactive Ingredients Aqua (Water), Glycerin, Allantoin, Aloe Barbadensis Leaf Juice Powder*, Acrylates/C13-30 Alkyl Acrylate Crosspolymer, Sorbitol, Sodium Hydroxide, Caprylyl Glycol, Phenoxethanol *Certified Organic

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

Acne Treatment Step 2. Treat
  • Budhi Acne Treatment, 5% Benzoyl Peroxide, helps kill bacteria, dry up acne blemishes and prevent new ones from forming
  • Specifically formulated for teens
  • Penetrates pores to help fight the Propionibacterium acnes bacteria that can cause acne
  • Benzoyl peroxide is considered the most effective over-the-counter drug for the treatment of acne
  • Effictive for back acne or "Backne"
  • Certified organic aloe vera soothes and aids in healing irritated skin
  • Allantoin is an effective anti-irritant that promotes healthy cell renewal.
  • No parabens, sodium lauryl/lauthreth sulfates, phthalates, alcohol, witch hazel or dyes
  • No potentially irritating essential oils
  • Gluten free
  • Fragrance free

budhi Teencare acne treatment
MAGIC MARKER 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66915-436
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide52.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Allantoin 
ALOE VERA LEAF 
Carbomer Copolymer TYPE A 
Sorbitol 
Sodium Hydroxide 
Caprylyl Glycol 
Phenoxyethanol 
Packaging
#Item CodePackage Description
1NDC:66915-436-011 TUBE (TUBE) in 1 CARTON
1NDC:66915-436-0436 g in 1 TUBE
2NDC:66915-436-02200000 g in 1 DRUM
3NDC:66915-436-037.5 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/09/2010
Labeler - CoValence Inc. (070659375)
Establishment
NameAddressID/FEIOperations
CoValence Inc.070659375manufacture

Revised: 09/2010
 
CoValence Inc.

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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