Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76540-100-02 - Packager: Universal Distributors 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 April 26, 2020
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 rub hand sanitizer (leave in product) which is intended to be used when soap and water are not available, and are left on and not rinsed off with water. It complies with the final rule on consumer antiseptic rubs, using alcohol in a percentage between 65 and 90%. The product is made with
- Alcohol (ethanol) (70%, volume/volume (v/v)) in an aqueous solution denatured.
- Glycerol (10% v/v).
- Isopropyl alcohol (1.33% v/v).
- Sterile distilled water or boiled cold water.
- Carbomer 940 (0.25% m/v)
- Polysorbate 20 (3.33% m/v)
The firm add only fragrance (0.002%) as an inactive ingredient, and realizes it may impact the quality and potency of the product.
- 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:76540-100 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 GLYCERIN (UNII: PDC6A3C0OX) 10 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.25 g in 100 mL WATER (UNII: 059QF0KO0R) THIOGLYCOLIC ACID TRIETHANOLAMINE (UNII: JPH0S6Q77R) 1.336 mL in 100 mL POLYSORBATE 20 (UNII: 7T1F30V5YH) 3.33 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76540-100-02 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/30/2020 Labeler - Universal Distributors LLC (080748869) Registrant - Universal Distributors LLC (080748869) Establishment Name Address ID/FEI Business Operations Universal Distributors LLC 080748869 relabel(76540-100) , repack(76540-100) , manufacture(76540-100)
