ANTI-BACTERIAL HAND BE THE SUNSHINE CITRUS SUNSHINE- alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Bath & Body Works, Inc.
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic Decrease bacteria on hands.
Authorization status:
OTC monograph not final
Authorization number:
62670-5923-0, 62670-5923-1, 62670-5923-3

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ANTI-BACTERIAL HAND BE THE SUNSHINE CITRUS SUNSHINE- 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.

----------

DRUG FACTS

ACTIVE INGREDIENT

Alcohol 71%

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

INACTIVE INGREDIENTS: Water (Aqua, Eau), Fragrance (Parfum), Carbomer, Citrus Aurantium

Dulcis (Orange) Peel Oil, Lactose, Propylene Glycol, Aminomethyl Propanol, Isopropyl Myristate,

Cellulose, Hydroxyethyl Urea, Tocopheryl Acetate, Wheat Amino Acids, Aloe Barbadensis Leaf

Juice, Butyrospermum Parkii (Shea) Butter Extract, Citrus Aurantifolia (Lime) Oil, Retinyl Palmitate,

Hydroxypropyl Methylcellulose, 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 BE THE SUNSHINE CITRUS SUNSHINE

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 26 70 -59 23

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 8 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 26 70 -59 23-

29 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/0 9 /20 20

2

NDC:6 26 70 -59 23-

73 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/0 9 /20 20

3

NDC:6 26 70 -59 23-

225 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 9 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

12/0 9 /20 20

Bath & Body Works, Inc.

Labeler -

Bath & Body Works, Inc. (878952845)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Accel Inc.

8 38 9 33430

re la be l(6 26 70 -59 23)

Revised: 12/2020

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