Label: SALIC-2- salicylic acid gel
- NDC Code(s): 50405-110-01
- Packager: SOHM Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 11, 2013
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- SPL UNCLASSIFIED SECTION
- Active ingredients
Salicylic Acid (2%)Close
- Uses For acne treatment
- Reduces the number of whiteheads, blackheads and acne blemishes.
For external use only
When using this product
- Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
- Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only one medication should be used unless directed by a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
- Clean the skin thoroughly before applying product.
- Cover the entire affected area with a thin layer one to three times daily.
- Relax for 2-3 minutes, then rinse.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or directed by a doctor.
- If both dryness and peeling occurs, reduce application to once a day or every other day.
- Other information
- Keep tightly closed
- Store in a cool & dry place.
- Inactive ingredients
Water, Propylene Glycol, Disodium Hydrogen Phosphate Anhydrous, Sodium Lauryl Sulphate, Chlorocresol, Carbopol 940, Fragrance SSC-929/BRHClose
- Questions ?
- SPL UNCLASSIFIED SECTION
Distributed by :
6920 Knott Ave., Suite A-C
Buena Park, CA 90621
Sohm (India) Pvt. Ltd. India.
- PRINCIPAL DISPLAY PANEL - 60g Tube Label
Salicylic Acid 2% Gel
A Complete Fresh Face Wash Gel
2.12 OZ 60g)
- INGREDIENTS AND APPEARANCE
salicylic acid gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50405-110 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 1.2 g in 60 g Inactive Ingredients Ingredient Name Strength Propylene Glycol (UNII: 6DC9Q167V3) Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F) Sodium Lauryl Sulfate (UNII: 368GB5141J) Chlorocresol (UNII: 36W53O7109) Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50405-110-01 60 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 11/15/2013 Labeler - SOHM Inc. (009303848)