ACNE SPOT TREATMENT WALGREENS- salicylic acid 2% stick

Acne Spot Treatment by

Drug Labeling and Warnings

Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Walgreens, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                    Purpose

Salicylic Acid….2%                    Acne Treatment

PURPOSE

Uses

For the treatment of acne

WarningsFor external use onlyFlammable. Keep away from fire or flame.

When using this product skin irritation and dryness is more likely 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

DOSAGE & ADMINISTRATION

Directions
Cleanse thoroughly before applying treatment
Cover the entire affected area with a thin layer one to three times daily.
Because of excessive drying of the skin may occurs, 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 usage to once a day or every other day.

Inactive ingredients

Beeswax
Eucalyptus Globulus Leaf Oil
Fragrance
Myristica Fragrans (Nutmeg) Kernel Oil
Petrolatum
Ricinus Communis (Castor) Seed Oil
Thymol
Thuja Occidentalis Leaf Oil
Tocopheryl Acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE SPOT TREATMENT  WALGREENS
salicylic acid 2% stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1115
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 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
EUCALYPTUS OIL (UNII: 2R04ONI662)
NUTMEG OIL (UNII: Z1CLM48948)
Petrolatum (UNII: 4T6H12BN9U)
CASTOR OIL (UNII: D5340Y2I9G)
Thymol (UNII: 3J50XA376E)
CEDAR LEAF OIL (UNII: BJ169U4NLG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1115-01	1 in 1 CARTON	01/15/2016
1		20 g 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	part333D	01/15/2016

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(0363-1115) , label(0363-1115)