Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 72686-189-05 - 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 February 22, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
- 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.
- WATER (AQUA)
c. GLYCERIN
d. FRAGRANCE (PARFUM)
e. ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
f. MANNITOL
g. ALOE BARBADENSIS LEAF JUICE
h. AMINOMETHYL PROPANOL
i. MICROCRYSTALLINE CELLULOSE
j. TOCOPHERYL ACETATE
k. CHROMIUM HYDROXIDE GREEN (CI 77289)
l. HYDROXYPROPYL METHYLCELLULOSE
m. CITRIC ACID
n. SODIUM BENZOATE
o. POTASSIUM SORBATE
- 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 and redness develops and persists.
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
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Inactive ingredients
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, AMINOMETHYL PROPANOL, CHROMIUM HYDROXIDE GREEN (CI 77289), CITRIC ACID, FRAGRANCE (PARFUM), GLYCERIN, HYDROXYPROPYL METHYLCELLULOSE, MANNITOL, MICROCRYSTALLINE CELLULOSE, POTASSIUM SORBATE, SODIUM BENZOATE, TOCOPHERYL ACETATE, WATER (AQUA).
- 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:72686-189 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 77 mL in 100 mL Inactive Ingredients Ingredient Name Strength AMINOMETHYLPROPANOL (UNII: LU49E6626Q) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0) WATER (UNII: 059QF0KO0R) CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MANNITOL (UNII: 3OWL53L36A) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) HYPROMELLOSES (UNII: 3NXW29V3WO) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72686-189-05 50 mL in 1 TUBE; Type 0: Not a Combination Product 02/22/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/22/2021 Labeler - Fareva Morton Grove, Inc. (116752326) Establishment Name Address ID/FEI Business Operations Fareva Morton Grove, Inc. 116752326 manufacture(72686-189) , analysis(72686-189) , label(72686-189) , pack(72686-189) , relabel(72686-189) , repack(72686-189)
