Label: INIXIAL PERFECTION MATT BALANCING CARE SALICYLIC ACID 2% ACNE TREATMENT- salicylic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70532-002-01 - Packager: IXXI S.A.S.
- 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 April 4, 2016
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
• 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.
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 (aqua), SD alcohol 40-B, coco-caprylate/caprate, bamboo (bambusa arundinacea) stem extract, glycerin, propanediol, citric acid, cellulose, hydrogenated coconut acid, sodium hydroxide, xylitylglucoside, glyceryl stearate citrate, alcohol, fragrance (parfum), anhydroxylitol, arachidyl, polyacrylate crosspolymer-6, behenyl alcohol, xylitol, cetearyl alcohol, chlorphenesin, xanthan gum, palmitoyl pine bark extract, arachidyl glucoside, orris (Iris florentina) root extract, tocopherol, glucose, wild soybean (glycine soja) oil, retinyl palmitate, zinc sulfate, sodium phytate, heather (calluna vulgaris) flower extract, t-butyl alcohol, palmitic acid, citronellol, alphaisomethyl ionone.
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INGREDIENTS AND APPEARANCE
INIXIAL PERFECTION MATT BALANCING CARE SALICYLIC ACID 2% ACNE TREATMENT
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70532-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) BAMBUSA BAMBOS STEM (UNII: NRA4497HC5) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POWDERED CELLULOSE (UNII: SMD1X3XO9M) SODIUM HYDROXIDE (UNII: 55X04QC32I) XYLITYLGLUCOSIDE (UNII: O0IEZ166FB) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) ALCOHOL (UNII: 3K9958V90M) ANHYDROXYLITOL (UNII: 8XWR7NN42F) DOCOSANOL (UNII: 9G1OE216XY) XYLITOL (UNII: VCQ006KQ1E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD) TOCOPHEROL (UNII: R0ZB2556P8) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ZINC SULFATE (UNII: 89DS0H96TB) PHYTATE SODIUM (UNII: 88496G1ERL) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) PALMITIC ACID (UNII: 2V16EO95H1) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70532-002-01 1 in 1 PACKAGE 04/03/2016 1 40 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 04/01/2016 Labeler - IXXI S.A.S. (263290505)
