Label: SEVEN THREE HAND SANITIZER- alcohol antiseptic 70% gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75219-7300-1 - Packager: Seven Three Distilling Company, LLC
- 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 9, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- 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.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
- Methacrylic Acid - Ethyl Acrylate Copolymer (5.5% v/v)
The firm does add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- Active Ingredient(s)
- Use
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Warnings
For external use only - hands.
Flammable. Keep away from heat or flame.
When usting this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.
Stop use and ask a doctor if skin irritation develops.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- Warnings
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WHEN USING
When using this product keep out of eyes. In case of contact with eyes, flush thoroghly with water.
Avoid contact with broken skin.
Do not ingest or inhale.
Stop use and ask a doctor if skin irritation develops.
Keep out of reach of children. If swallowed, get medical help or help or contact a Poison Control Center right away.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Purpose
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
SEVEN THREE HAND SANITIZER
alcohol antiseptic 70% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75219-7300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 0.125 mL in 100 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) 0.002 mL in 100 mL METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 5.5 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75219-7300-1 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Seven Three Distilling Company, LLC (087822184) Establishment Name Address ID/FEI Business Operations Seven Three Distilling Company, LLC 087822184 manufacture(75219-7300)
