Label: ATALA BIO HAND SANITIZER- didecyldimonium chloride and benzalkonium chloride liquid gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 77396-050-01, 77396-050-02, 77396-050-03 - Packager: Kemix Quimica, S.A. de C.V.
- 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 September 17, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
-
WHEN USING
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. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ATALA BIO HAND SANITIZER
didecyldimonium chloride and benzalkonium chloride liquid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77396-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE 2.5 mg in 0.001 L BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1 mg in 0.001 L Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) METHYL ALCOHOL (UNII: Y4S76JWI15) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77396-050-01 4 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/01/2020 2 NDC:77396-050-02 0.075 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/01/2020 3 NDC:77396-050-03 0.25 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/01/2020 Labeler - Kemix Quimica, S.A. de C.V. (813182128) Registrant - Kemix Quimica, S.A. de C.V. (813182128) Establishment Name Address ID/FEI Business Operations Kemix Quimica, S.A. de C.V. 813182128 manufacture(77396-050) , label(77396-050)
