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

Drug Labeling and Warnings

Drug Details [pdf]

ANTI-BACTERIAL HAND  APPLE AND CEDARWOOD- 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, Aminomethyl Propanol, Isopropyl Myristate, Propylene Glycol, Hydroxyethyl Urea, Wheat Amino Acids, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter Extract, 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

AB HG Apple and CedarwoodAB HG Apple and CedarwoodAB HG Apple and CedarwoodAB HG Apple and CedarwoodAB HG Apple and CedarwoodAB HG Apple and Cedarwood

ANTI-BACTERIAL HAND   APPLE AND CEDARWOOD
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62670-6537
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62670-6537-029 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/202312/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/23/202312/23/2023
Labeler - Bath & Body Works, Inc. (878952845)
Establishment
NameAddressID/FEIBusiness Operations
KDC US Holdings, Inc.080783283manufacture(62670-6537)
Establishment
NameAddressID/FEIBusiness Operations
Memphis Contract Packaging117443103manufacture(62670-6537)

Revised: 6/2023
Document Id: c02cb72b-85d9-4ead-ac43-567e0aca383e
Set id: 181204fa-249d-4a35-ad30-240ac37a73a7
Version: 1
Effective Time: 20230623