Salicylic Acid Gel [Goodier Cosmetics Llc] -

SALICYLIC ACID GEL [GOODIER COSMETICS LLC]
PDF | XML

NDC	10477-9697-1, 10477-9697-2
Set ID	a71a9ef2-ae6f-4280-a589-6f658a08b816
Category	HUMAN OTC DRUG LABEL
Packager	Goodier Cosmetics LLC
Generic Name
Product Class
Product Number
Application Number	PART333D

View All Sections

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	09/05/2016

Labeler - Goodier Cosmetics LLC (007317209)

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

View All Sections

Medic

SALICYLIC ACID GEL [GOODIER COSMETICS LLC]

Related Drugs