BIOGERM SANITIZER- benzalkonium chloride spray 
QUIMICA ROSMAR S.A. DE C.V.

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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77251-005 Benzalkonium chloride 0.13%

Active Ingredient(s)

Benzalkonium Chloride 0.13% v/v. Purpose: Antiseptic

Purpose

Antiseptic, full body Sanitizer

Use

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

Warnings

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

Do not use

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 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

Propylene glycol, glycerin, aloe vera leaf, water, metylparaben

Package Label - Principal Display Panel

60 g NDC: 77251-005-01

Biogerm Spray 100 g

190 g NDC: 77251-005-02

Biogerm Spray 190 g

300 g NDC: 77251-005-03

Bioferm Spray 300 g

430 g NDC: 77251-005-04

Biogerm Spray 430 g

BIOGERM SANITIZER 
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77251-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77251-005-0160 g in 1 BOTTLE; Type 0: Not a Combination Product10/26/2020
2NDC:77251-005-02190 g in 1 BOTTLE; Type 0: Not a Combination Product10/26/2020
3NDC:77251-005-03300 g in 1 BOTTLE; Type 0: Not a Combination Product10/26/2020
4NDC:77251-005-04430 g in 1 BOTTLE; Type 0: Not a Combination Product10/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/26/2020
Labeler - QUIMICA ROSMAR S.A. DE C.V. (814223475)
Establishment
NameAddressID/FEIBusiness Operations
QUIMICA ROSMAR S.A. DE C.V.814223475manufacture(77251-005) , label(77251-005) , pack(77251-005)

Revised: 10/2021
Document Id: cea33aa3-5e0a-4282-e053-2995a90ab84d
Set id: b2d4ed25-c98a-5943-e053-2995a90ab7c9
Version: 2
Effective Time: 20211018
 
QUIMICA ROSMAR S.A. DE C.V.