Define Health Alcohol Wipes (Vietnam)

Define Health Alcohol Wipes by

Drug Labeling and Warnings

Define Health Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by Define Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80444-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80444-002-50	50 in 1 POUCH	12/01/2020	12/31/2021
1		5.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/01/2020	12/31/2021

Labeler - Define Health, LLC (036745170)

Revised: 12/2021

Document Id: d30a9fee-b175-62f0-e053-2a95a90aac1e

34390-5

Set id: b56ea4d7-a830-21fb-e053-2a95a90a0f45

Version: 2

Effective Time: 20211213