Label: ZO SKIN HEALTH ACNE CONTROL BENZOYL PEROXIDE- benzoyl peroxide cream
- NDC Code(s): 42851-087-60
- Packager: ZO Skin Health, Inc.
- 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 May 30, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
-
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.
- avoid unnecessary sun exposure and use a sunscreen
- 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 or in a lower concentration.
-
Directions
Sensitivity Test 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 below.
- 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 Information
-
Inactive Ingredients
Aqua/Water/Eau, Aspalathus Linearis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-40 Stearate, PEG-8 Laurate, Phenoxyethanol, Pinus Strobus Bark Extract, Polyglyceryl-6 Isostearate, Propanediol, Propylene Glycol, Silica, Sodium Citrate, Sodium Hydroxide, Sorbitan Stearate, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton
-
INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH ACNE CONTROL BENZOYL PEROXIDE
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-087 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) DOCUSATE SODIUM (UNII: F05Q2T2JA0) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) TEA TREE OIL (UNII: VIF565UC2G) PEG-40 STEARATE (UNII: ECU18C66Q7) PEG-8 LAURATE (UNII: 762O8IWA10) PHENOXYETHANOL (UNII: HIE492ZZ3T) PINUS STROBUS BARK (UNII: 8PJ4761097) POLYGLYCERYL-6 ISOSTEARATE (UNII: 5VKGO1O03G) PROPANEDIOL (UNII: 5965N8W85T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) VITIS VINIFERA SEED (UNII: C34U15ICXA) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-087-60 1 in 1 CARTON 05/25/2023 1 60 mL 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 05/25/2023 Labeler - ZO Skin Health, Inc. (826468527)
