INIXIAL PERFECTION MATT BALANCING CARE SALICYLIC ACID 2% ACNE TREATMENT- salicylic acid cream 
IXXI S.A.S.

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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Inixial Perfection MATT BALANCING CARE Salicylic Acid 2% Acne Treatment Solution

Drug Facts

Active ingredients

Salicylic acid 2%

Purpose


Acne treatment solution

Uses

• For the treatment of acne.

• Dries and clears acne blemishes and allows skin to heal.

• Helps prevent new acne blemishes.

Warnings

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

Keep out of reach of children.

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

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.

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.

Questions?

Call toll-free 1-800-322-3507

Package Labeling:

Label2

INIXIAL PERFECTION MATT BALANCING CARE SALICYLIC ACID 2% ACNE TREATMENT 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70532-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70532-002-011 in 1 PACKAGE04/03/2016
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/01/2016
Labeler - IXXI S.A.S. (263290505)

Revised: 4/2016
Document Id: 2fade6d6-e059-62e8-e054-00144ff88e88
Set id: c25458b5-aa2c-4b06-a6e7-390aca351b0d
Version: 2
Effective Time: 20160404
 
IXXI S.A.S.