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.

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

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