GERM CLEAN- benzalkonium chloride cloth

GERM CLEAN by

Drug Labeling and Warnings

GERM CLEAN by is a Otc medication manufactured, distributed, or labeled by NATURATLALI S DE RL DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium chloride 0.13% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

WHEN USING

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children.

STOP USE

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

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

Directions

• Gently pull wipe from the dispenser feed.
• Wipe hands thoroughly with product and let dry.
• Discard wipe in trash.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

purified water, glycerin USP, benzyl alcohol, caprylyl/capryl oligoglucoside, iodopropynyl butylcarbamate, methylisothiazolinone, anhydrous citric acid, fragrance.

Package Label - Principal Display Panel

350 mL NDC: 77143-006-01

INGREDIENTS AND APPEARANCE

GERM CLEAN 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77143-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.7 mL  in 100 mL
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)	0.0625 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)	1 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.003 mL  in 100 mL
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)	0.125 mL  in 100 mL
GLYCERYL OLEATE (UNII: 4PC054V79P)	0.125 mL  in 100 mL
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	0.0625 mL  in 100 mL
FRAGARIA VESCA FRUIT JUICE (UNII: 59KX3YNN28)	0.04 mL  in 100 mL
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)	0.08 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77143-006-01	350 mL in 1 POUCH; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020

Labeler - NATURATLALI S DE RL DE CV (951577202)

Establishment
Name	Address	ID/FEI	Business Operations
NATURATLALI S DE RL DE CV		951577202	manufacture(77143-006) , pack(77143-006) , label(77143-006)