Bath & Body Works, Inc. DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

ANTI-BACTERIAL HAND  TIKI SHORE- 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,
Propylene Glycol, Hydroxyethyl Urea, Wheat Amino Acids,
Tocopheryl Acetate, Retinyl Palmitate, Glycerin,
Hydroxypropyl Methylcellulose, Aloe Barbadensis Leaf
Juice, Elaeis Guineensis (Palm) Extract, Cocos Nucifera
(Coconut) Fruit Extract,
Honey Extract (Mel, Extrait de miel), Olea Europaea
(Olive) Fruit Extract, Ultramarines (CI 77007),
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

ANTI-BACTERIAL HAND   TIKI SHORE
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-5627
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: 62670-5627-0	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2019	12/20/2019
2	NDC: 62670-5627-1	73 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2019	12/20/2019
3	NDC: 62670-5627-3	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/20/2019	12/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/20/2019	12/20/2019

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

Revised: 6/2019

Document Id: 9c3813e7-d660-491b-85f9-92a1c894d455

34390-5

Set id: 14f4f044-cc0b-4fef-85ba-db13e944407f

Version: 4

Effective Time: 20190620

 

Bath & Body Works, Inc.