Label: HAND SANITIZER- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77143-002-02, 77143-002-03, 77143-002-04, 77143-002-05, view more77143-002-06, 77143-002-07, 77143-002-08, 77143-002-09, 77143-002-10, 77143-002-11, 77143-002-12, 77143-002-13, 77143-002-14, 77143-002-15, 77143-002-16, 77143-002-17, 77143-002-22 - Packager: NATURATLALI S DE RL DE CV
- 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 February 23, 2021
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
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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
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Package Label - Principal Display Panel
500 mL NDC: 77143-002-02
250 mL NDC: 77143-002-03
5000 mL NDC: 77143-002-04
1000 mL NDC: 77143-002-05
1000 mL NDC: 77143-002-06
500 mL NDC: 77143-002-07
500 mL NDC: 77143-002-08
250 mL NDC: 77143-003-09
5000 mL NDC: 77143-002-10
3785 mL NDC: 77143-002-11
5000 mL NDC: 77143-002-12
250 mL NDC: 77143-002-13
500 mL NDC: 77143-002-14
1000 mL NDC: 77143-002-15
3785 mL NDC: 77143-002-16
3785 mL NDC: 77143-002-17
100 mL NDC: 77143-002-22
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77143-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.25 mL in 100 mL HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) 0.1 g in 100 mL WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) 0.025 g in 100 mL PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.025 g in 100 mL DMDM HYDANTOIN (UNII: BYR0546TOW) 0.025 g in 100 mL FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.005 g in 100 mL DIPROPYLENE GLYCOL (UNII: E107L85C40) 0.025 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77143-002-05 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 11/23/2020 2 NDC:77143-002-10 5000 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/30/2020 11/23/2020 3 NDC:77143-002-06 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 11/23/2020 4 NDC:77143-002-02 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 5 NDC:77143-002-03 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 6 NDC:77143-002-04 5000 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/30/2020 7 NDC:77143-002-07 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 11/23/2020 8 NDC:77143-002-08 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 11/23/2020 9 NDC:77143-002-09 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 11/23/2020 10 NDC:77143-002-11 3785 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/30/2020 11/23/2020 11 NDC:77143-002-12 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 11/23/2020 12 NDC:77143-002-13 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 11/23/2020 13 NDC:77143-002-14 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 11/23/2020 14 NDC:77143-002-15 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 11/23/2020 15 NDC:77143-002-16 3785 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/30/2020 11/23/2020 16 NDC:77143-002-17 3785 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/30/2020 17 NDC:77143-002-22 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - NATURATLALI S DE RL DE CV (951577202) Registrant - NATURATLALI S DE RL DE CV (951577202) Establishment Name Address ID/FEI Business Operations NATURATLALI S DE RL DE CV 951577202 manufacture(77143-002) , pack(77143-002) , label(77143-002)