OXY TOTAL CARE VITAMIN C SERUM- salicylic acid solution 
The Mentholatum Company

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.

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Drug Facts

Active ingredient

Salicylic acid 0.5%

Purpose

Salicylic acid – Acne treatment

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

For the treatment of acne.
Helps prevent new acne blemishes.

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.

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.

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

Questions?1-877-636-2677

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Package/Label Principal Display Panel

Oxy Vitamin C Serum
OXY  TOTAL CARE VITAMIN C SERUM
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-1315-11 in 1 CARTON09/30/2019
137 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/30/2019
Labeler - The Mentholatum Company (002105757)

Revised: 5/2019
 
The Mentholatum Company