DISINFECTING WIPES- hand sanitizer cloth

DISINFECTING WIPES by

Drug Labeling and Warnings

DISINFECTING WIPES by is a Otc medication manufactured, distributed, or labeled by Tmd Holdings, Llc, Fuan Huh Bio Tech co.,Ltd, Zhangzhou KangBei Hyginenic Products Co.,Ltd, ZHEJIANG BINGER NONWOVEN CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.184% w/w, Purspose: Antimicrobial

Didecyldimonium Chloride 0.2% w/w, Purspose: Antimicrobial

Purpose

Antiseptic, Hand Sanitizer

Use

For hand washing to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

STOP USE

Stop use and ask a doctor if irritation develops and persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• For use apply thoroughly to hands as desired. Allow to dry without wiping. Discard wipe in trash after use. Do not flush.
• For dispensing flip open dispensing cap and remove entire lid from canister by lifting upward.
• Locate wipe at center of roll, twist corner to a point and thread through small opening in lid.
• DO NOT PUSH FINGER THROUGH OPENING.
• Replace lid and pull sheet up at an angle. Remaining wipes feed automatically.
• When finished, snap lid cap shut to retain moisture.

Other information

• Store below 110F(43C)
• May discolor certain fabrics.

Inactive ingredients

Ethylhexylglycerin, Glycerin, Fragrance(Parfum), Phenoxyethanol, Propylene Glycol, Purified water

Package Label - Principal Display Panel

160 Wipes NDC: 80297-031-01

INGREDIENTS AND APPEARANCE

DISINFECTING WIPES 
hand sanitizer cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80297-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.184 g  in 100 g
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.1 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.1 g  in 100 g
WATER (UNII: 059QF0KO0R)	98.786 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.5 g  in 100 g
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.1 g  in 100 g
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.03 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80297-031-01	1050 g in 1 PAIL; Type 0: Not a Combination Product	08/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/26/2020

Labeler - Tmd Holdings, Llc (962827502)

Registrant - Tmd Holdings, Llc (962827502)

Establishment
Name	Address	ID/FEI	Business Operations
Fuan Huh Bio Tech co.,Ltd		415711361	manufacture(80297-031)

Establishment
Name	Address	ID/FEI	Business Operations
Zhangzhou KangBei Hyginenic Products Co.,Ltd		415797593	manufacture(80297-031)

Establishment
Name	Address	ID/FEI	Business Operations
ZHEJIANG BINGER NONWOVEN CO., LTD.		529311763	manufacture(80297-031)