Label: DAILY LEAVE ON ACNE TREATMENT MASK- benzoyl peroxide cream
- NDC Code(s): 62742-4212-1, 62742-4212-2
- Packager: Allure Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 April 2, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
-
WHEN USING
When using this product
• Avoid unnecessary sun
exposure & use a sunscreen
• Avoid contact with the
eyes, lips, and mouth
• Avoid contact with hair &
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
- KEEP OUT OF REACH OF CHILDREN
-
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 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.
- OTHER SAFETY INFORMATION
-
INACTIVE INGREDIENT
Inactive Ingredients
Water (Aqua), Aloe Barbadensis
Leaf Juice, Glycerin, Serenoa
Serrulata (Saw Palmetto) Fruit
Extract, Niacinamide, Linoleic
Acid, Linolenic Acid, Docosahexaenoic
Acid, Eicosapentaenoic
Acid, Scutellaria Baicalensis
Root Extract, Zinc Gluconate,
Tocopherol, Dimethicone,
Silica, Carbomer, Caprylyl
Glycol, Diethylhexyl Sodium
Sulfosuccinate, Ethylhexylglycerin,
Hexylene Glycol, PEG-40
Stearate, Phenoxyethanol,
Propanediol, Sodium
Hydroxide, Sodium Citrate,
Sodium Phytate, Sorbitan
Stearate, Xanthan Gum.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAILY LEAVE ON ACNE TREATMENT MASK
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4212 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 25 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LINOLENIC ACID (UNII: 0RBV727H71) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PROPANEDIOL (UNII: 5965N8W85T) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) DOCONEXENT (UNII: ZAD9OKH9JC) SAW PALMETTO (UNII: J7WWH9M8QS) NIACINAMIDE (UNII: 25X51I8RD4) ICOSAPENT (UNII: AAN7QOV9EA) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-40 STEARATE (UNII: ECU18C66Q7) SODIUM CITRATE (UNII: 1Q73Q2JULR) PHYTATE SODIUM (UNII: 88496G1ERL) XANTHAN GUM (UNII: TTV12P4NEE) LINOLEIC ACID (UNII: 9KJL21T0QJ) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) TOCOPHEROL (UNII: R0ZB2556P8) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DOCUSATE SODIUM (UNII: F05Q2T2JA0) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4212-2 1 in 1 CARTON 04/02/2022 1 NDC:62742-4212-1 45 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 04/02/2022 Labeler - Allure Labs (926831603) Registrant - Allure Labs (926831603) Establishment Name Address ID/FEI Business Operations Allure LAbs 926831603 manufacture(62742-4212)
