Bath & Body Works, Inc. DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

ANTI-BACTERIAL HAND  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 68%

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),
Isopropyl Alcohol, Fragrance (Parfum),
Carbomer, Lactose, Propylene Glycol,
Aminomethyl Propanol, Isopropyl Myristate,
Cellulose, 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),
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   ORANGE SUNRISE
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-5888
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: 62670-5888-0	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/03/2020	12/03/2020
2	NDC: 62670-5888-1	73 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/03/2020	12/03/2020
3	NDC: 62670-5888-3	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/03/2020	12/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/03/2020	12/03/2020

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

Revised: 6/2020

Document Id: 56acd895-af63-4048-90ac-4bf47f7e21f6

34390-5

Set id: 091fc1a2-f108-44c6-95ae-063acefe82ca

Version: 4

Effective Time: 20200603