Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78217-002-01, 78217-002-02, 78217-002-03, 78217-002-04, view more78217-002-05 - Packager: FRSH HANDS LLC
- This is a repackaged label.
- Source NDC Code(s): 77808-002
- Category: HUMAN OTC DRUG LABEL
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 July 14, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerin (1.45% v/v).
- Carbopol 940.
- Triethanolamine
- Essential Oil
- Sterile distilled water or boiled cold water.
- 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:78217-002(NDC:77808-002) 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 CARBOMER 940 (UNII: 4Q93RCW27E) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78217-002-01 59.147 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/20/2020 2 NDC:78217-002-02 118.294 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/20/2020 3 NDC:78217-002-03 236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/20/2020 4 NDC:78217-002-04 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/20/2020 5 NDC:78217-002-05 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/20/2020 Labeler - FRSH HANDS LLC (117524588)
