Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77143-004-01, 77143-004-02, 77143-004-03, 77143-004-05, view more77143-004-06, 77143-004-08, 77143-004-10, 77143-004-11, 77143-004-12, 77143-004-18 - 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 November 10, 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
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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
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77143-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 2 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.5 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 TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK) 1 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77143-004-01 250 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/30/2020 2 NDC:77143-004-02 236 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/30/2020 3 NDC:77143-004-03 473 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/30/2020 4 NDC:77143-004-05 946 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/30/2020 5 NDC:77143-004-06 3785 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/30/2020 6 NDC:77143-004-08 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 7 NDC:77143-004-10 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/14/2020 8 NDC:77143-004-11 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 9 NDC:77143-004-12 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 10 NDC:77143-004-18 125 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 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 pack(77143-004) , manufacture(77143-004) , label(77143-004)
