KEY DERMOXINE JABON ESPUMA- jabon antiseptico en espuma liquid

Key Dermoxine Jabon Espuma by

Drug Labeling and Warnings

Key Dermoxine Jabon Espuma by is a Otc medication manufactured, distributed, or labeled by Key Química S.A. de C.V., Cyan Labs S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Gluconato de Clorhexidina 4 %

Purpose

Antiseptic

Use

To decrease bacteria on skin that could cause diseases. Recommend for repeated use.

Warnings

Flammable, keep away from fire or flame. For external use only.

Do not use

Do not use this product in or near the eyes.

Stop use

Stop use if irritation or redness develop. If conditions persist for more than 72 hours, consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, seek inmediate medical attention or call a poison control center.

Directions

Wet hands thoroughly with product and rinse after.

Innactive ingredients

Water (aqua), Isopropyl Alcohol, Cocamine Oxide, Glycerin and Polyquaternium-7.

Package Label - Principal Display Panel

Key Demorxine Jabón Espuma

INGREDIENTS AND APPEARANCE

KEY DERMOXINE JABON ESPUMA 
jabon antiseptico en espuma liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58345-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII: U1G23TFV1K)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
COCAMINE OXIDE (UNII: QWA2IZI6FI)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58345-104-01	3 in 1 BOX	04/29/2024
1		1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 58345-104-02	3 in 1 BOX	04/29/2024
2		1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	04/29/2024

Labeler - Key Química S.A. de C.V. (810740548)

Establishment
Name	Address	ID/FEI	Business Operations
Cyan Labs S.A. de C.V.		812754130	analysis(58345-104) , label(58345-104) , manufacture(58345-104) , pack(58345-104)