Alcohol: Package Insert and Label Information

ALCOHOL- alcohol 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.

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

label2
(click image for full-size original)

ALCOHOL
74021-0007 liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74021-0007
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
GLYCERIN 1.45 mL in 100 mL
HYDROGEN PEROXIDE 0.125 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74021-0007-1 750 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/25/2020
Labeler — Bacardi Bottling Corporation (061916110)
Registrant — Bacardi Bottling Corporation (061916110)
Establishment
Name Address ID/FEI Operations
Bacardi Bottling Corporation 061916110 manufacture (74021-0007)

Revised: 04/2020 Bacardi Bottling Corporation

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.