Label: INIXIAL PERFECTION PURITY SALICYLIC ACID 0.5% ACNE TREATMENT- salicylic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 70532-003-01 - Packager: IXXI S.A.S.
- Category: HUMAN OTC DRUG LABEL
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
- Shake vigorously until powder dissolves.
- 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, maritime pine (pinus pinaster) bark extract, bamboo (bambusa arundinacea) stem extract, cellulose, PEG-6 caprylic/capric glycerides, polysorbate 20, citric acid, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, ethylhexyl methoxycinnamate, fragrance (parfum), sodium hydroxide, propanediol, PEG-35 castor oil, hydrogenated coconut acid, alcohol, butyl methoxydibenzoyl methane, ethylhexyl salicylate, Tocopheryl acetate, sodium phytate, sodium benzoate,coco-caprylate/caprate, potassium sorbate, orris (Iris florentina) root extract, glycerin, palmitoyl pine bark extract, retinyl palmitate, zinc sulfate, heather (calluna vulgaris) flower extract, palmitic acid.
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INGREDIENTS AND APPEARANCE
INIXIAL PERFECTION PURITY SALICYLIC ACID 0.5% ACNE TREATMENT
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70532-003 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) MARITIME PINE (UNII: 50JZ5Z98QY) POWDERED CELLULOSE (UNII: SMD1X3XO9M) PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8) POLYSORBATE 20 (UNII: 7T1F30V5YH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) OCTINOXATE (UNII: 4Y5P7MUD51) SODIUM HYDROXIDE (UNII: 55X04QC32I) PROPANEDIOL (UNII: 5965N8W85T) POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) ALCOHOL (UNII: 3K9958V90M) AVOBENZONE (UNII: G63QQF2NOX) OCTISALATE (UNII: 4X49Y0596W) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHYTATE SODIUM (UNII: 88496G1ERL) SODIUM BENZOATE (UNII: OJ245FE5EU) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD) GLYCERIN (UNII: PDC6A3C0OX) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ZINC SULFATE (UNII: 89DS0H96TB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70532-003-01 1 in 1 CARTON 04/03/2016 1 200 mL in 1 BOTTLE; 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)