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

Drug Labeling and Warnings

Drug Details [pdf]

ANTI-BACTERIAL HAND  CHAMPAGNE TOAST- 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), 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   CHAMPAGNE TOAST
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-6527
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: 62670-6527-0	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2022	06/20/2023
2	NDC: 62670-6527-1	73 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2022	06/20/2023
3	NDC: 62670-6527-3	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/20/2022	06/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/20/2022	06/20/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Memphis Contract Packaging		185390010	manufacture(62670-6527)

Revised: 12/2022

Document Id: b07de579-786c-4653-a023-ccb6c619f174

34390-5

Set id: 1537be71-776f-40c0-8e43-017bebd91d24

Version: 1

Effective Time: 20221220