Label: HAND SANITIZER- alcohol gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 78900-631-10, 78900-631-11 - Packager: Innovative Tool and design
- 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 25, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
-
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
-
INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78900-631 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape SEMI-CIRCLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78900-631-10 474 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/26/2020 2 NDC:78900-631-11 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/26/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/26/2020 Labeler - Innovative Tool and design (011289563) Registrant - Innovative Tool and design (011289563) Establishment Name Address ID/FEI Business Operations Innovative Tool and design 011289563 relabel(78900-631) Establishment Name Address ID/FEI Business Operations Ningbo Meiteli Cosmetic co. 546624772 manufacture(78900-631)