Label: SPOT ACNE TREATMENT- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-7782-01 - Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 30, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients Purpose
- PURPOSE
- Use
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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.
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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
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INGREDIENTS AND APPEARANCE
SPOT ACNE TREATMENT
salicylic acid gelProduct 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)
