BLUE HERBAL SPOT TREATMENT SALICYLIC ACID ACNE TREATMENT- salicylic acid gel

Blue Herbal Spot Treatment Salicylic Acid Acne Treatment by

Drug Labeling and Warnings

Blue Herbal Spot Treatment Salicylic Acid Acne Treatment by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Cosmetic Essence, LLC, Paklab, L'OREAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Use

• for the treatment of acne

Warnings

For external use only

When using this products

• 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

• 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

Inactive ingredients

water, alcohol denat., glycerin, butylene glycol, methyl methacrylate crosspolymer, ammonium polyacryloyldimethyl taurate, perlite, nylon-12, dipropylene glycol, xanthan gum, peumus boldus leaf extract, boswellia serrata extract, hamamelis virginiana (witch hazel) water, t-butyl alcohol, camphor, menthol, zingiber officinale (ginger) root extract, sanuisorba officinalis root extract, cinnamomum cassia bark extract, phenoxyethanol, cinnamal, laminaria saccharina extract, zinc sulfate, pyridoxine HCl, sodium hydroxide, citric acid

Questions or comments?

Call toll free 1-800-946-4453

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BLUE HERBAL SPOT TREATMENT SALICYLIC ACID ACNE TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
PERLITE (UNII: 0SG101ZGK9)
NYLON-12 (UNII: 446U8J075B)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
XANTHAN GUM (UNII: TTV12P4NEE)
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
GINGER (UNII: C5529G5JPQ)
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)
CHINESE CINNAMON (UNII: WS4CQ062KM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
ZINC SULFATE (UNII: 89DS0H96TB)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-602-01	1 in 1 CARTON	01/01/2016
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/01/2016

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		032565959	manufacture(49967-602)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		005917047	pack(49967-602)