INIXIAL PERFECTION PURITY SALICYLIC ACID 0.5% ACNE TREATMENT- salicylic acid liquid

Inixial Perfection PURITY Salicylic Acid 0.5% Acne Treatment by

Drug Labeling and Warnings

Inixial Perfection PURITY Salicylic Acid 0.5% Acne Treatment by is a Otc medication manufactured, distributed, or labeled by IXXI S.A.S.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Salicylic acid 0.5%

Purpose

Acne treatment lotion

Uses

For the treatment of acne.

Dries and clears acne blemishes and allows skin to heal.

Helps prevent new acne blemishes.

Warnings

Flammable: Keep away from fine and flame.

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

• 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.

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.

Questions?

Call toll free 1-800-322-3507

Package Labeling:

INGREDIENTS AND APPEARANCE

INIXIAL PERFECTION PURITY SALICYLIC ACID 0.5% ACNE TREATMENT 
salicylic acid liquid

Product 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)