Label: ASTRINGENT- salicylic acid liquid
- NDC Code(s): 50594-875-34
- Packager: Big Lots
- 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 March 7, 2022
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- Official Label (Printer Friendly)
- Active ingredinet
- Purpose
- Use
- Warnings
- When using this product
- Keep out of reach of children.
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Directions
- clean the skin thoroughly before applying this product
- cover the entire affected are with a thin layer and rinse thoroughly one to three times daily
- because excessive drying of the sking may occur, start with one application daily, then grdually increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day
- inactvie ingredients
- SPL UNCLASSIFIED SECTION
- principal display panel
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INGREDIENTS AND APPEARANCE
ASTRINGENT
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-875 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK) ALOE VERA LEAF (UNII: ZY81Z83H0X) SULISOBENZONE (UNII: 1W6L629B4K) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) ISOCETETH-20 (UNII: O020065R7Z) PEG-32 DIOLEATE (UNII: TOM07RFH74) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) water (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50594-875-34 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 03/15/2016 Labeler - Big Lots (017885351) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(50594-875) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(50594-875)