Label: HAND SANITIZER ORIGINAL- seersucker original hand san liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 80750-0002-1 - Packager: Azar Distilling, LLC
- This is a repackaged label.
- Source NDC Code(s): 74793-0001
- 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 13, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Seersucker Original
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) (80%, 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.
- 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 ORIGINAL
seersucker original hand san liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80750-0002(NDC:74793-0001) 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 GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) VANILLA (UNII: Q74T35078H) 0.05 mL in 100 mL MYRRH OIL (UNII: H74221J5J4) 0.05 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80750-0002-1 118 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 - Azar Distilling, LLC (080288797) Registrant - Azar Distilling, LLC (080288797) Establishment Name Address ID/FEI Business Operations Azar Distilling, LLC 080288797 label(80750-0002) , repack(80750-0002)
118 mL NDC: 80750-0001-1