Label: CHEMSTATION ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 80291-002-01, 80291-002-02, 80291-002-03, 80291-002-04 - Packager: CHEMSTATION SOUTHERN CALIFORNIA, INC.
- 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 August 27, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
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Warnings
For external use only.
Do not use- in children less than 2 months of age
- on open skin wounds
- in eyes
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Product label
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INGREDIENTS AND APPEARANCE
CHEMSTATION ALCOHOL FREE HAND SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80291-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCAMIDOPROPYL DIMETHYLAMINE PROPIONATE (UNII: 83750MLC4A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80291-002-01 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/28/2020 2 NDC:80291-002-02 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/28/2020 3 NDC:80291-002-03 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/28/2020 4 NDC:80291-002-04 3.785 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/28/2020 Labeler - CHEMSTATION SOUTHERN CALIFORNIA, INC. (825479186) Establishment Name Address ID/FEI Business Operations CHEMSTATION SOUTHERN CALIFORNIA, INC. 825479186 manufacture(80291-002)
