Label: JABON AVENA- benzalkonium chloride 0.1% soap
- NDC Code(s): 62476-101-15, 62476-101-38
- Packager: Industria La Popular, S.A.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 June 21, 2023
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- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
- Inactive Ingredients
- Questions
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INGREDIENTS AND APPEARANCE
JABON AVENA
benzalkonium chloride 0.1% soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62476-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 110 g Inactive Ingredients Ingredient Name Strength SODIUM PALM KERNELATE (UNII: 6H91L1NXTW) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) PRUNUS DULCIS BARK (UNII: 32F32E1WJJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIMETHICONE (UNII: 92RU3N3Y1O) ETIDRONIC ACID (UNII: M2F465ROXU) OAT KERNEL OIL (UNII: 3UVP41R77R) BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62476-101-38 110 g in 1 CELLO PACK; Type 0: Not a Combination Product 05/01/2020 2 NDC:62476-101-15 440 g in 1 CELLO PACK; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2020 03/31/2025 Labeler - Industria La Popular, S.A. (846044576) Registrant - Industria La Popular, S.A. (846044576)