Label: 62% ALCOHOL HAND SANITIZER- hand sanitizer gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 78495-015-01 - Packager: Ultra Distributors Inc
- 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 December 23, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
-
WARNINGS
Warnings: Highly flammable liquid and vapour. Causes serious eye iritation. May cause skin iritation. Keep away from heat, sparks, hot surfaces, fire, open flame and sources of ignition. No smoking. Keep at room temperature. Store in a well-ventilated, cool and dry place, away from direct sunlight. Do not store above 40 °C
For external use only.
Avoid contact with eyes. If in eyes, rinse immediately with clean water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Do not swallow. If swallowed, rinse mouth and seek medical advice immediately and show this label. Do not induce vomiting. Do not use on damage, inflamed or broken skin. If iritation or redness develops, discontinue use.
Keep out of the reach of babies, children & animals.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- Front Panel and Back Panel Art
-
INGREDIENTS AND APPEARANCE
62% ALCOHOL HAND SANITIZER
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78495-015 Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 146.32 mL in 236 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78495-015-01 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/07/2020 Labeler - Ultra Distributors Inc (007160073) Establishment Name Address ID/FEI Business Operations Ultra Distributors 007160073 relabel(78495-015) Establishment Name Address ID/FEI Business Operations Ningbo Home Solution Corp., LTD 679868836 manufacture(78495-015)