Label: ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel
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NDC Code(s):
70204-513-01,
70204-513-02,
70204-513-03,
70204-513-04, view more70204-513-05, 70204-513-06
- Packager: Hit Promotional Products, Inc.
- This is a repackaged label.
- Source NDC Code(s): 65133-120
- 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 January 1, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Antibacterial Hand Sanitizer
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- DOSAGE & ADMINISTRATION
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70204-513(NDC:65133-120) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70204-513-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2020 08/31/2024 2 NDC:70204-513-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2020 08/31/2024 3 NDC:70204-513-03 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2020 08/31/2024 4 NDC:70204-513-04 118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/13/2020 08/31/2024 5 NDC:70204-513-05 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/13/2020 08/31/2024 6 NDC:70204-513-06 437 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/13/2020 08/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/13/2020 08/31/2024 Labeler - Hit Promotional Products, Inc. (081070202)