Label: RUSH SALICYLC ACID COMPLEXION PADS- salicylic acid liquid
- NDC Code(s): 65113-1201-1, 65113-1201-2
- Packager: G.S. COSMECEUTICAL USA, INC.
- 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 13, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
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Directions
- Clean the skin thoroughly before applying this product
- Cover the entire affected area with a thin layer and rinse thoroughly 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
- Other Information
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Inactive Ingredients
Aqua/Water/Eau, SD Alcohol 40-B (Alcohol Denat), Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Water, Lactic Acid, Urea, Sodium PCA, Sodium Hydroxide, Phenoxyethanol, Alcohol, Allantoin, Menthyl Lactate, Rosa Canina Fruit Extract, Parfum/Fragrance, Benzyl Benzoate, Citronellol, Geraniol, Hexyl Cinnamal, Linalool
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 Pad Jar Carton
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INGREDIENTS AND APPEARANCE
RUSH SALICYLC ACID COMPLEXION PADS
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65113-1201 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 Water (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Butylene Glycol (UNII: 3XUS85K0RA) Witch Hazel (UNII: 101I4J0U34) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Urea (UNII: 8W8T17847W) Sodium Hydroxide (UNII: 55X04QC32I) Phenoxyethanol (UNII: HIE492ZZ3T) Allantoin (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65113-1201-1 1 in 1 CARTON 04/15/2019 1 75 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:65113-1201-2 1 in 1 CARTON 04/15/2019 2 37 g in 1 JAR; 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 04/15/2019 Labeler - G.S. COSMECEUTICAL USA, INC. (017014734) Establishment Name Address ID/FEI Business Operations G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(65113-1201)