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

Drug Details [pdf]

ANTI-BACTERIAL HAND FRESH RAINFALL- 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),
Yellow 5 (CI 19140), Green 3 (CI 42053),
Ext. Violet 2 (CI 60730).

PRODUCT PACKAGING

AB HG Fresh Rainfall

ANTI-BACTERIAL HAND FRESH RAINFALL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-5818
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 62670-5818-0	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020	11/22/2020
2	NDC: 62670-5818-1	73 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020	11/22/2020
3	NDC: 62670-5818-3	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/22/2020	11/22/2020

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Accel Inc.		838933430	relabel(62670-5818)

Revised: 5/2020

Document Id: 19f07cc2-591b-4057-9719-5783ec82105d

Set id: 0debda99-b0fd-4a17-bf19-5785e46ece2c

Version: 4

Effective Time: 20200522