Alcohol: Package Insert and Label Information

ALCOHOL- alcohol gel
Relief-Mart, Inc

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.

Alcohol
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Use

Use — For hand-washing to decrease bacteria on the skin, only when water is not available.

Purpose

Antiseptic

Stop Use

irritation and redness develop

Warning Section

Flammable, keep away from fire and flames. For external use only.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away.

Inactive Ingredients

Glycerin, carbopol, water, propylene glycol, fragrance

Label

Label

ALCOHOL
hand safe hand sanitizer gel gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67285-104
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER 9.4 g in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE 0.4 g in 100 mL
ALOE VERA LEAF 0.2 g in 100 mL
PROPYLENE GLYCOL 5 g in 100 mL
GLYCERIN 5 g in 100 mL
AMINOMETHYLPROPANOL 0.25 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67285-104-02 59 mL in 1 BOTTLE, DISPENSING None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/02/2020
Labeler — Relief-Mart, Inc (124312344)
Establishment
Name Address ID/FEI Operations
Generitech Corporation 138352435 manufacture (67285-104)

Revised: 07/2020 Relief-Mart, Inc

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