Label: HAND SANITIZER- alcohol gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 72686-188-05 - Packager: Fareva Morton Grove, 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 15, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
SPL UNCLASSIFIED SECTION
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (77%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
b. Glycerinc. FRAGRANCE (PARFUM)
d. ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
e. ALOE BARBADENSIS LEAF JUICEf. AMINOMETHYL PROPANOL
g. RED 4 (CI 14700)
h. CITRIC ACID
i. SODIUM BENZOATE
j. POTASSIUM SORBATE
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- 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:72686-188 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 78 mL in 100 mL Inactive Ingredients Ingredient Name Strength AMINOMETHYLPROPANOL (UNII: LU49E6626Q) GLYCERIN (UNII: PDC6A3C0OX) FRAGRANCE JUNIPERBERRY ORANGE ORC2000843 (UNII: 2KS3NF08B2) WATER (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALOE (UNII: V5VD430YW9) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72686-188-05 50 mL in 1 TUBE; Type 0: Not a Combination Product 12/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/15/2020 Labeler - Fareva Morton Grove, Inc. (116752326) Establishment Name Address ID/FEI Business Operations Fareva Morton Grove, Inc 116752326 manufacture(72686-188) , analysis(72686-188) , label(72686-188) , pack(72686-188) , relabel(72686-188) , repack(72686-188)