ACNE FIGHTING FOUNDATION CARAMEL- salicylic acid cream

Acne Fighting Foundation Caramel by

Drug Labeling and Warnings

Acne Fighting Foundation Caramel by is a Otc medication manufactured, distributed, or labeled by Zhejiang Ayan Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

ACNE FIGHTING FOUNDATION CARAMEL 
salicylic acid cream

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/01/2018

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

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