Label: HAND SANITIZER- ethyl alcohol liquid
- NDC Code(s): 78684-080-01
- Packager: STILL VALLEY SPIRITS LLC
- 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 June 23, 2020
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- Drug Facts
- Active ingredient(s)
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Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
• on children less than 2 months of age
• on open skin wounds
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
- Directions
- Other information
- Inactive ingredient(s)
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78684-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDROGEN PEROXIDE (UNII: BBX060AN9V) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78684-080-01 750 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/15/2020 Labeler - STILL VALLEY SPIRITS LLC (122659099) Establishment Name Address ID/FEI Business Operations STILL VALLEY SPIRITS LLC 122659099 manufacture(78684-080)