Bath & Body Works, Inc. DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

ANTI-BACTERIAL HAND  AMERICAN APPLE- 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,
Aminomethyl Propanol, Isopropyl Myristate, Cellulose,
Hydroxyethyl Urea, Propylene Glycol, Wheat Amino Acids,
Tocopheryl Acetate, Retinyl Palmitate, Glycerin,
Hydroxypropyl Methylcellulose, Aloe Barbadensis Leaf
Juice, Elaeis Guineensis (Palm) Extract, Olea Europaea
(Olive) Fruit Extract, Honey Extract (Mel, Extrait de
miel), Cocos Nucifera (Coconut) Fruit Extract,
Ultramarines (CI 77007), Yellow 5 (CI 19140),
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   AMERICAN APPLE
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-5633
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: 62670-5633-0	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2019	12/19/2019
2	NDC: 62670-5633-1	73 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2019	12/19/2019
3	NDC: 62670-5633-3	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/19/2019	12/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/19/2019	12/19/2019

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

Revised: 6/2019

Document Id: 2198031a-61ad-44b9-9979-5f3465bec373

34390-5

Set id: d0cf6bbd-d0b9-4cb5-a548-74e776b3383c

Version: 4

Effective Time: 20190619

 

Bath & Body Works, Inc.