Salicylic Acid by Goodier Cosmetics LLC SALICYLIC ACID gel

Salicylic Acid by

Drug Labeling and Warnings

Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by Goodier Cosmetics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACNE TREATMENT GEL

Active Ingredient

Salicylic Acid 2%

​Purpose

Acne Treatment

​Uses

For the treatment of acne.

DOSAGE & ADMINISTRATION

​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. If eye contact
occurs, flush thoroughly with water.

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
two times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually
increase to two times daily if needed or as directed by a physician. If bothersome dryness or peeling occurs, reduce
application to once a day or every other day.

​Inactive ingredients

Water (Aqua), Butylene Glycol, Glycerin, Ethoxydiglycol, Neopentyl Glycol Dicaprylate/Dicaprate, Lactic Acid,
Sodium Lactate, Avena Sativa (Oat) Kernel Extract, Squalane, Panthenol, Lauryl Lactate, Potassium Sorbate,
Methyl Glucose Sesquistearate, Disodium EDTA, Ergothioneine, Sodium Hyaluronate, Hydroxyethyl Acrylate/Sodium
Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Sodium Hydroxide, Bisabolol, Xanthan Gum, Phenoxyethanol,
Carbomer

SPL UNCLASSIFIED SECTION

Distributed by: Adigica Health, Inc
San Diego, CA 92121
Made in U.S.A

PRINCIPAL DISPLAY PANEL

1 floz Tube

1 floz Label

2 floz Tube

INGREDIENTS AND APPEARANCE

SALICYLIC ACID 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10477-9697
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
LACTIC ACID (UNII: 33X04XA5AT)
SODIUM LACTATE (UNII: TU7HW0W0QT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
PANTHENOL (UNII: WV9CM0O67Z)
LAURYL LACTATE (UNII: G5SU0BFK7O)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10477-9697-1	30 mL in 1 TUBE; Type 0: Not a Combination Product	09/05/2016
2	NDC: 10477-9697-2	59 mL in 1 TUBE; Type 0: Not a Combination Product	09/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/05/2016

Labeler - Goodier Cosmetics LLC (007317209)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics LLC		007317209	manufacture(10477-9697)