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

Drug Labeling and Warnings

Drug Details [pdf]

ANTI-BACTERIAL HAND  WASH THOSE PAWS (ORANGE SUNRISE)- 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

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), Red 40 (CI 16035), Yellow 5 (CI
19140), 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   WASH THOSE PAWS (ORANGE SUNRISE)
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-6162
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: 62670-6162-0	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2021	06/09/2022
2	NDC: 62670-6162-1	73 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2021	06/09/2022
3	NDC: 62670-6162-3	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/09/2021	06/09/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/09/2021	06/09/2022

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

Establishment
Name	Address	ID/FEI	Business Operations
KDC US Holdings, Inc.		080783283	manufacture(62670-6162)

Revised: 12/2021

Document Id: 25b5f9aa-bd30-4e46-b727-e6db3132b2bd

34390-5

Set id: 06ff541d-87be-4daf-bb11-dd1a552edf2b

Version: 1

Effective Time: 20211209