KEY DERMOLAC- jabon antiseptico a base de acido lactico liquid

Key Dermolac by

Drug Labeling and Warnings

Key Dermolac 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

- L-(+)-lactic acid 1.6 %

Purpose

Antiseptic

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 center.

Inactive ingredients

- Water

- Sodium Laureth Sulfate

- Sodium chloride

- Cocamidopropyl betaine

- Sodium hydroxide

- Tetrasodium EDTA

- Acid Red 14

- Direct Red 81

Directions

Wet hands thoroughly with product ant rise at the end.

Use

To decrease bacteria on skin that could cause diseases.

Warnings

- For external use only.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KEY DERMOLAC 
jabon antiseptico a base de acido lactico liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58345-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N)	LACTIC ACID, L-	1.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
DIRECT RED 81 (UNII: 7E49Q56PNB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
CARMOISINE (UNII: DR4641L47F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58345-105-01	3 in 1 BOX	07/02/2024
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC: 58345-105-02	4 in 1 BOX	07/02/2024
2		4000 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58345-105-03	4 in 1 BOX	07/02/2024
3		4000 mL in 1 BOTTLE, PUMP; 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)	07/02/2024

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(58345-105) , label(58345-105) , manufacture(58345-105) , pack(58345-105)