Bath & Body Works, Inc. / Accel Inc. DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

ANTI-BACTERIAL HAND  SALTED COCONUT WATER (SHELL YEAH)- 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, Tocopheryl
Acetate, Wheat Amino Acids, Aloe Barbadensis Leaf
Juice, Butyrospermum Parkii (Shea) Butter Extract,
Hydroxypropyl Methylcellulose, Retinyl Palmitate,
Ultramarines (CI 77007), Blue 1 (CI 42090),
Red 33 (CI 17200), 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   SALTED COCONUT WATER (SHELL YEAH)
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-5851
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: 62670-5851-0	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020	11/22/2020
2	NDC: 62670-5851-1	73 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020	11/22/2020
3	NDC: 62670-5851-3	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/22/2020	11/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/22/2020	11/22/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Accel Inc.		838933430	relabel(62670-5851)

Revised: 5/2020

Document Id: f082dd1e-e45e-4df6-b8e3-0ca638d40019

34390-5

Set id: 3e01376a-8187-4bc8-9d53-25a353cbb84d

Version: 4

Effective Time: 20200522