KOLMED HAND SANITIZING WIPES- benzalkonium chloride cloth

KOLMED HAND SANITIZING WIPES by

Drug Labeling and Warnings

KOLMED HAND SANITIZING WIPES by is a Otc medication manufactured, distributed, or labeled by SHANGHAI SANJUN GENERAL MERCHANDISE CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium chloride 0.2%

Purpose

Antiseptic

Uses

hand wipes to decrease bacteria on the skin

recommended for repeated use

for use when soap and water are not available

Warnings

For external use only

Do not use

in children less than 2 months of age

on open skin wounds

When using this product do not get into eyes. In case of contact, rinse eyes thoroughly with water. Do not inhale

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

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

Directions

wet hands thoroughly with product and allow to dry without wiping

supervise children under 6 years of age when using this product to avoid swallowing

discard wipe in trash after use. Do not flush

Other information

store between 15-30°C (59-86°F)

avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT

Inactive ingredients aloe vera (Aloe barbadensis) leaf juice, citric acid, decyl glucoside, ethylhexylglycerin,

fragrance, glycerin, phenoxyethanol, polysorbate 20, potassium sorbate, sodium benzoate,tocopheryl acetate, water

SPL UNCLASSIFIED SECTION

3X STRONGER

Kills 99% OF COMMON GERMS*

COTTONY SOFT

NON-ALCOHOL FORMULA

Crisp Orange

GENTLE ON HANDS

EXTRA SOFT WIPE WITH ALOE

√ Kills 99% of many common harmful germs and bacteria*

√ Removes light soils and dirt from hands

√ Gentle on hands

√ Multi-layered Wipe. 3X Stronger vs. Paper Towel1

TO OPEN PACKAGE:

1. Pull out wipe from center of roll.

2. Next sheet pops up automatically.

3. Close lid to retain moisture.

STORAGE AND DISPOSAL:

Dispose of wipe in trash after use. Do not flush. Tightly close lid between uses to retain moisture.

Non refillable container. Do not reuse or refill this empty container.

Offer empty container for recycling. If recycling is not available, discard container in trash.

Questions or Comments?

Please visit www.kolmedusa.com.

Mon-Fri 9AM-6PM PST

Distributed by:

Passhion Inc

3192 Factory Dr, Pomona, CA, 91768

KOLMED is a registered trademark of Passhion Inc

Made in China

Packaging

INGREDIENTS AND APPEARANCE

KOLMED HAND SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75670-008
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75670-008-01	85 in 1 CANISTER	08/17/2020
1		4.41 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 75670-008-02	4 in 1 BOX	08/17/2020
2		85 in 1 CANISTER
2		4.41 g in 1 PACKAGE; 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	part333A	08/17/2020

Labeler - SHANGHAI SANJUN GENERAL MERCHANDISE CO., LTD. (527500109)

Establishment
Name	Address	ID/FEI	Business Operations
SHANGHAI SANJUN GENERAL MERCHANDISE CO., LTD.		527500109	manufacture(75670-008)