GERM CLEAN- benzalkonium chloride cloth 
NATURATLALI S DE RL DE CV

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.

----------

77143-006
Toallitas sanitizantes

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.

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 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.

Directions

Other information

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

PDP wipes - 350 mL

GERM CLEAN 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77143-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77143-006-01350 mL in 1 POUCH; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2020
Labeler - NATURATLALI S DE RL DE CV (951577202)
Establishment
NameAddressID/FEIBusiness Operations
NATURATLALI S DE RL DE CV951577202manufacture(77143-006) , pack(77143-006) , label(77143-006)

Revised: 11/2020
Document Id: b5118ce5-67d1-acbc-e053-2995a90a4183
Set id: aa9647a1-648d-3e6b-e053-2a95a90a24fe
Version: 2
Effective Time: 20201127
 
NATURATLALI S DE RL DE CV