Bath & Body Works, Inc. / KDC US Holdings, Inc. / Memphis Contract Packaging DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

ANTI-BACTERIAL HAND  LAVENDER AND VANILLA- 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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DRUG FACTS

ACTIVE INGREDIENT

Alcohol 71%

PURPOSE

Antiseptic

USE

Decrease 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), Fragrance (Parfum), Carbomer, Lactose, Aminomethyl Propanol, Isopropyl Myristate, Cellulose, Propylene Glycol, Hydroxyethyl Urea, Tocopheryl Acetate, Wheat Amino Acids, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter Extract, Hydroxypropyl Methylcellulose, Retinyl Palmitate, Ultramarines (CI 77007), Ext. Violet 2 (CI 60730), Yellow 5 (CI 19140).

COMPANY INFORMATION

Bath & Body Works, Distr.
Reynoldsburg, Ohio 43068
1-800-395-1001
www.bathandbodyworks.com

PRODUCT PACKAGING

ANTI-BACTERIAL HAND   LAVENDER AND VANILLA
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-6556
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: 62670-6556-0	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2023	12/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/23/2023	12/23/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
KDC US Holdings, Inc.		080783283	manufacture(62670-6556)

Establishment
Name	Address	ID/FEI	Business Operations
Memphis Contract Packaging		117443103	manufacture(62670-6556)

Revised: 6/2023

Document Id: 9fa6e504-21dc-4865-a7ae-0074e6929475

34390-5

Set id: 18167ce0-2f74-4072-ac93-05c5f60f1dbb

Version: 1

Effective Time: 20230627