ALCOHOL- 74021-0008 liquid
Bacardi Bottling Corporation

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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Alcohol 80% v/v

Antiseptic

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

• in children less than 2 months of age
• on open skin wounds

. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

For external use only. Flammable. Keep away from heat or flame

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

glycerin, hydrogen peroxide, purified water USP

Label

ALCOHOL
74021-0008 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74021-0008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74021-0008-1	750 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/25/2020

Labeler - Bacardi Bottling Corporation (061916110)

Registrant - Bacardi Bottling Corporation (061916110)

Name	Address	ID/FEI	Business Operations
Establishment
Bacardi Bottling Corporation		061916110	manufacture(74021-0008)