Drug Facts

Active ingredients

Salicylic Acid 0.5%

Purpose

Acne Treatment

Uses

For the treatment of acne
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

clear 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.

Inactive ingredients

Water (Aqua), Cyclopentasiloxane, Dimethicone, Ethoxydiglycol, Propylene Glycol, PEG-10 Dimethicone, Hydrogenated Polyisobutene, Cyclohexasiloxane, Nylon-12, Dimethicone Crosspolymer, Dimethicone/PEG-10/15 Crosspolymer, Triethoxycaprylylsilane, Talc, Quaternium-18 Bentonite, Magnesium Sulfate, Butylene Glycol, Aloe Barbadensis Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cinnamomum Camphora (Camphor) Bark Oil, Glycerin, Palmitoyl Hexapeptide-12, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, MAY CONTAIN: Titanium Dioxide (CI 77891), Red Iron Oxide (CI 77491), Yellow Iron Oxide (CI 77492), Black Iron Oxide (CI 77499)

Questions or comments?

1-855-353-7320

Package Labeling:

Outer Package Inner Package

ACNE FIGHTING FOUNDATION CARAMEL
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70412-435
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
NYLON-12 (UNII: 446U8J075B)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TALC (UNII: 7SEV7J4R1U)
BENTOQUATAM (UNII: 7F465U79Q1)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WITCH HAZEL (UNII: 101I4J0U34)
TEA TREE OIL (UNII: VIF565UC2G)
CAMPHOR OIL (UNII: 75IZZ8Y727)
GLYCERIN (UNII: PDC6A3C0OX)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70412-435-01	1 in 1 BOX	11/01/2018
1		36 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M006	11/01/2018

Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Ayan Biotech Co.,Ltd.		544377996	manufacture(70412-435)

Acne Fighting Foundation Caramel