Label: INIXIAL PERFECTION STOP BLEMISHES SALICYLIC ACID 2% ACNE TREATMENT- salicylic acid cream
- 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.
Updated April 4, 2016
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- Drug Facts
- Active ingredients
For external use only
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, only use one topical acne medication at a time
- 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.
water (aqua), SD alcohol 40-B, propanediol, citric acid, bamboo (Bambusa arundinacea) stem extract, cellulose, sodium hydroxide, polycrylate crosspolymer-6, alcohol, xanthan gum, glycerin, orris (Iris florentina) root extract, hydrogenated coconut acid, retinyl palmitate, zinc sulfate, sodium phytate, t-butyl alcohol, heather (Calluna vulgaris) flower extract, coco-caprylate/caprate, palmitoyl pine bark extract, palmitic acid.
- Package Labeling:
INGREDIENTS AND APPEARANCE
INIXIAL PERFECTION STOP BLEMISHES SALICYLIC ACID 2% ACNE TREATMENT
salicylic acid cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70532-004 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 PALMITIC ACID (UNII: 2V16EO95H1) WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POWDERED CELLULOSE (UNII: SMD1X3XO9M) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALCOHOL (UNII: 3K9958V90M) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) IRIS PALLIDA ROOT (UNII: LVV57EM5OG) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ZINC SULFATE (UNII: 89DS0H96TB) PHYTATE SODIUM (UNII: 88496G1ERL) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) CALLUNA VULGARIS FLOWERING TOP (UNII: D9PC510CQV) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70532-004-01 1 in 1 CARTON 04/03/2016 1 10 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)