Label: OXY TOTAL CARE VITAMIN C SERUM- salicylic acid solution
- NDC Code(s): 10742-1315-1
- 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 June 28, 2023
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- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
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Warnings
For external use only.
When using this product
- keep away from eyes. If contact occurs, flush thoroughly with water.
- 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.
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 one to three drops to 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.
- 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.
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Inactive Ingredients
water, ethoxydiglycol, butylene glycol, glycerin, disteareth-100 IPDI, 3-O-ethyl ascorbic acid [vitamin C], PEG-8 dimethicone, PEG-8 ricinoleate, citric acid, fragrance, ganoderma lucidum [mushroom] extract, hyaluronic acid, potassium sorbate, propanediol, silanetriol, sodium benzoate, xanthan gum
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INGREDIENTS AND APPEARANCE
OXY TOTAL CARE VITAMIN C SERUM
salicylic acid solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-1315 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) DISTEARETH-100 ISOPHORONE DIISOCYANATE (UNII: P37PW4M0IS) 3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P) PEG-8 DIMETHICONE (UNII: GIA7T764OD) PEG-8 RICINOLEATE (UNII: DM36F4D2OU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) REISHI (UNII: TKD8LH0X2Z) HYALURONIC ACID (UNII: S270N0TRQY) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPANEDIOL (UNII: 5965N8W85T) SILANETRIOL (UNII: E52D0J3TS5) SODIUM BENZOATE (UNII: OJ245FE5EU) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-1315-1 1 in 1 CARTON 09/30/2019 1 37 mL in 1 VIAL, GLASS; 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(10742-1315)
