ANTIBACTERIAL - alcohol gel
Continental Manufacturing Chemist, 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.

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Active ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Use(s)

To decrease bacteria on skin

Warnings

For external use only

Flammable! Keep away from fire or flame. Do not use in eye; if this happens rinse thoroughly with water.

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if

When using this product

Stop use and ask a doctor if

irritation or redness develops and persists more than 72 hours

Pregnancy/Breastfeeding

Keep out of reach of children

If ingested get medical help or contact a Poison Control Center right away

Directions

Wet hands thoroughly with product and allow to dry without wiping. Children under six should be supervised while using this product.

Other information

Storage

Do not store above 105F (40C)

Inactive ingredients

Amino Methyl Propanol, Carbomer, FD&C Blue #1, Fragrance, Propylene Glycol, Purified Water

Questions

Principal Display Panel

Bulk Product Labeling

Antibacterial Gel Labels

ANTIBACTERIAL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49794-009
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (ALCOHOL)	ALCOHOL	620 g in 1.0 kg

Inactive Ingredients
Ingredient Name	Strength
2-ETHYLAMINOETHANOL	2.1 g in 1.0 kg
CARBOMER COPOLYMER TYPE A	2.5 g in 1.0 kg
FD&C BLUE NO. 1	0.001788 g in 1.0 kg
GLYCERIN	6.0 g in 1.0 kg
PROPYLENE GLYCOL	3.0 g in 1.0 kg
WATER	363.4 g in 1.0 kg

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:49794-009-99	1000 kg in 1 CONTAINER	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	09/01/2011

Labeler - Continental Manufacturing Chemist, Inc. (005278007)

Revised: 12/2011 Continental Manufacturing Chemist, Inc.