Label: ACNE DEFENSE DAILY TREATMENT SERUM MERLE NORMAN- benzoyl peroxide gel
- NDC Code(s): 57627-202-01, 57627-202-02
- Packager: Merle Norman Cosmetics
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated January 27, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
Do not use if
- have very senstive skin
- are sensitive to benzoyl peroxide
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.
Avoid unnecessary sun exposure and use a sunscreen
avoid contact with 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. Irriration may be reduced by using the product less frequently or in a lower concentration
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DOSAGE & ADMINISTRATION
Directions
- Clean the skin thoroughly before applying this product
- Cover the entire affected area with a thin layer 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 directed by a doctor. If bothersome dryness or peeing 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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE DEFENSE DAILY TREATMENT SERUM MERLE NORMAN
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PENTYLENE GLYCOL (UNII: 50C1307PZG) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-202-02 1 in 1 CARTON 07/14/2017 1 NDC:57627-202-01 33 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/14/2017 Labeler - Merle Norman Cosmetics (008479388) Registrant - Merle Norman Cosmetics (008479388) Establishment Name Address ID/FEI Business Operations Merle Norman Cosmetics 008479388 manufacture(57627-202)
