DEFINE HEALTH ALCOHOL WIPES- alcohol cloth

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Define Health, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antiseptic Uses - to decrease bacteria on the skin - recommended for repeated use
Authorization status:
OTC monograph not final
Authorization number:
80444-002-50

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DEFINE HEALTH ALCOHOL WIPES- alcohol cloth

Define Health, LLC

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.

----------

Define Health Alcohol Wipes (Vietnam)

Drug Facts

Active ingredient

Alcohol 75%

Purpose

Antiseptic

Uses

to decrease bacteria on the skin

recommended for repeated use

Warnings

For external use only

Flammable, keep away from fire or flame

When using this product keep away from eyes.In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

immediately.

Directions

rub wipe thoroughly over all surfaces of both hands and allow to dry

supervise children under 6 years old

not recommended for infants

discard wipe in trash;do not flush

Inactive ingredients Benzalkonium Chloride, Citric Acid, Polyaminopropyl Biguanide, Water

50 WIPES

1 Wipe = 180mm x 207mm

(7.1 x 8.15 inches)

MANUFACTURED FOR DEFINE HEALTH, LLC

6065 Roswell Road Ste 940

Atlanta GA 30328

MADE IN VIETNAM

DEFINE HEALTH

ALCOHOL WIPES

ANTISEPTIC HAND SANITIZER

CONTAINS 75% ALCOHOL

50 WIPES

DEFINE HEALTH ALCOHOL WIPES

alcohol cloth

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 0 444-0 0 2

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

75 mL in 10 0 mL

Define Health, LLC

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

PO LYAMINO PRO PYL BIGUANIDE (UNII: DT9 D8 Z79 ET)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:8 0 444-0 0 2-

50 in 1 POUCH

12/0 1/20 20

1

5.5 mL in 1 APPLICATOR; Type 0 : No t a Co mbinatio n

Pro duc t

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 1/20 20

Labeler -

Define Health, LLC (036745170)

Revised: 12/2020

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