SPOT ACNE TREATMENT- salicylic acid gel

Spot Acne Treatment by

Drug Labeling and Warnings

Spot Acne 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 ingredients                 Purpose

Salicylic Acid - 2.0%              Acne Medication 

PURPOSE

Use

Helps prevent new acne blemishes

For external use onlyFlammable, keep away from oipen 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 the children
If product is swallowed, get medical help or contact a Poison Control Center right away

Avoid contact with eyes. If contact occurs, flush thoroughly with water

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

Alcohol
Ammonium Hydroxide
Benzalkonium Chloride
Butylene Glycol
C12-15 Alkyl Lactate
C13-14 Isoparaffin
Capryloyl Glycine
Cedrus Atlantica Bark Extract
Cetyl Lactate
Cinnamomum Zeylanicum Bark Extract
Cocamidopropyl PG-Dimonium Chloride Phosphate
Cyclopentasiloxane
Dehydroxanthan Gum
Denatonium Benzoate
Fragrance
Glycerin
Hamamelis Virginiana (Witch Hazel) Water
Laureth-7
Phenoxyethanol
Polyacrylamide
Polysorbate 20
Portulaca Oleracea Extract
PPG-2 Isoceteth-20 Acetate
Propylene Glycol
Sarcosine
t-Butyl Alcohol
Tetrasodium EDTA
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPOT ACNE TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-7782
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
Alcohol (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Butylene Glycol (UNII: 3XUS85K0RA)
C12-15 Alkyl Lactate (UNII: GC844VRD7E)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Capryloyl Glycine (UNII: 8TY5YO42NJ)
CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)
Cetyl Lactate (UNII: A7EVH2RK4O)
CINNAMON BARK OIL (UNII: XE54U569EC)
Cocamidopropyl PG-Dimonium Chloride Phosphate (UNII: H2KVQ74JM4)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Dehydroxanthan Gum (UNII: 63ZP7I1BQO)
Denatonium Benzoate (UNII: 4YK5Z54AT2)
Glycerin (UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
Laureth-7 (UNII: Z95S6G8201)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 20 (UNII: 7T1F30V5YH)
PURSLANE (UNII: M6S840WXG5)
PPG-2 Isoceteth-20 Acetate (UNII: BI6C7YO419)
Propylene Glycol (UNII: 6DC9Q167V3)
Sarcosine (UNII: Z711V88R5F)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-7782-01	21 g in 1 TUBE; Type 0: Not a Combination Product	04/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/17/2018

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(0363-7782)