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
Drug Label Information
Updated December 13, 2024
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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 Drug M006 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)