Label: OXY TOTAL CARE CLARIFYING MOISTURIZER- benzoyl peroxide lotion
- NDC Code(s): 10742-1314-1
- Packager: The Mentholatum Company
- 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 February 7, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
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Warnings
For external use only.
Do not use if you
- have very sensitive 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, use only 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.
Stop use and ask a doctor if irritation becomes severe.
If pregnant or breast-feeding, ask a health professional before use.
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Directions
- clean the skin thoroughly before applying this product
- use a dime-sized amount to cover the entire affected area with a thin layer one to two 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.
- 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 above.
Other information
- THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
- KEEP TIGHTLY CLOSED
- avoid storing at temperatures above 100°F (38°C)
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Inactive Ingredients
water, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, hyaluronic acid, hydrolyzed algin, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, phytic acid, portulaca oleracea extract, silanetriol, sodium citrate, sodium hydroxide, xanthan gum, zinc sulfate
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INGREDIENTS AND APPEARANCE
OXY TOTAL CARE CLARIFYING MOISTURIZER
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-1314 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 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) HYALURONIC ACID (UNII: S270N0TRQY) ALGINIC ACID (UNII: 8C3Z4148WZ) LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H) PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85) PHENOXYETHANOL (UNII: HIE492ZZ3T) FYTIC ACID (UNII: 7IGF0S7R8I) PURSLANE (UNII: M6S840WXG5) SILANETRIOL (UNII: E52D0J3TS5) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SODIUM HYDROXIDE (UNII: 55X04QC32I) XANTHAN GUM (UNII: TTV12P4NEE) ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CHLORPHENESIN (UNII: I670DAL4SZ) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-1314-1 1 in 1 CARTON 09/30/2019 1 100 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 09/30/2019 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-1314)
