BIOGERM SANITIZER- benzalkonium chloride spray

BioGerm Sanitizer by

Drug Labeling and Warnings

BioGerm Sanitizer by is a Otc medication manufactured, distributed, or labeled by QUIMICA ROSMAR S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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 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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

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

Package Label - Principal Display Panel

60 g NDC: 77251-005-01

190 g NDC: 77251-005-02

300 g NDC: 77251-005-03

430 g NDC: 77251-005-04

INGREDIENTS AND APPEARANCE

BIOGERM SANITIZER 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77251-005
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 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77251-005-01	60 g in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2020
2	NDC: 77251-005-02	190 g in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2020
3	NDC: 77251-005-03	300 g in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2020
4	NDC: 77251-005-04	430 g in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/26/2020

Labeler - QUIMICA ROSMAR S.A. DE C.V. (814223475)

Establishment
Name	Address	ID/FEI	Business Operations
QUIMICA ROSMAR S.A. DE C.V.		814223475	manufacture(77251-005) , label(77251-005) , pack(77251-005)