Drug Labeling and Warnings

Drug Details [pdf]

ANTI-BACTERIAL HAND FRESH BALSAM- alcohol gel 
Bath & Body Works, 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

Alcohol 68%

PURPOSE

Antiseptic

USE

Decreases bacteria on hands.

WARNINGS

For external use only.

WHEN USING THIS PRODUCT

keep out of eyes.

STOP USE AND ASK A DOCTOR

if irritation or redness develops.

FLAMMABLE

Keep away from flame or high heat.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• Rub a dime sized drop into hands.

INACTIVE INGREDIENTS

Water (Aqua, Eau), Isopropyl Alcohol, Fragrance (Parfum), Carbomer, Lactose, Aminomethyl Propanol, Isopropyl Myristate, Cellulose, Propylene Glycol, Hydroxyethyl Urea, Wheat Amino Acids, Tocopheryl Acetate, Retinyl Palmitate, Hydroxypropyl Methylcellulose, Aloe Barbadensis Leaf Juice, Glycerin, Honey Extract (Mel, Extrait de miel), Elaeis Guineensis (Palm) Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Ultramarines (CI 77007), Yellow 6 (CI 15985), Yellow 5 (CI 19140), Red 33 (CI 17200), Red 40 (CI 16035), Ext. Violet 2 (CI 60730).

COMPANY INFORMATION

Bath & Body Works, Distr.

Reynoldsburg, Ohio 43068

1-800-395-1001

www.bathandbodyworks.com

PRODUCT PACKAGING

ANTI-BACTERIAL HAND  FRESH BALSAM
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-5541
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62670-5541-0	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2018	06/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/05/2018	06/05/2019

Labeler - Bath & Body Works, Inc. (878952845)

Revised: 12/2018

Document Id: 8d748ba6-f458-4dfc-a939-05449239ba11

34390-5

Set id: a5fc3f4f-6276-4541-a30e-c9124a553d2e

Version: 1

Effective Time: 20181205

 

Bath & Body Works, Inc.