Germiderm Hand Sanitizer by REAL NUTRICION Y BELLEZA, S.A. de C.V Germiderm Hand Sanitizer

Germiderm Hand Sanitizer by

Drug Labeling and Warnings

Germiderm Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by REAL NUTRICION Y BELLEZA, S.A. de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GERMIDERM HAND SANITIZER- benzalkonium chloride gel 
REAL NUTRICION Y BELLEZA, 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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Germiderm Hand Sanitizer

Active Ingredient(s)

• Active Ingredient: Purpose
• Benzalkonium choloride 0.13% v/v..............................: Antiseptic

Purpose

Antiseptic

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. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

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.

Directions

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

Other information

• Store between 68F to 77F (20 TO 25C)
• do not expose to excessive heat

TAMPER EVIDENT: Do not use if seal under cap is torn or missing.

Inactive ingredients

aloe vera leaf, benzyl alcohol, carbomer 940, ethylexylglycerin, fragrance, glycerin, trolamine, water

Package Label - Principal Display Panel

500 mL NDC: 78040-100-17

GERMIDERM HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78040-100
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78040-100-17	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/20/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/20/2020	12/31/2021

Labeler - REAL NUTRICION Y BELLEZA, S.A. de C.V (813583432)

Revised: 1/2023

Document Id: 06301102-983a-5cf8-e063-6294a90a20fe

34390-5

Set id: a746c5b6-a932-4709-e053-2995a90af94d

Version: 4

Effective Time: 20230101