MENTOL CHINO CONCENTRATED- methyl salicylate, menthol cream MENTOL CHINO FORTE- methyl salicylate, menthol, camphor cream BENZO DERMA- benzoic acid, salicylic acid, sulfur cream

BENZO DERMA by

Drug Labeling and Warnings

BENZO DERMA by is a Otc medication manufactured, distributed, or labeled by LABORATORIOS H.G. C.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

AGAINST ECZEMA, PIMPLES AND OTHER SKIN CONDITIONS

ACTIVE INGREDIENTS

BENZOIC ACID 6.0 g, SALYCYLIC ACID 2.5 g, SULFUR 4.6 g

PURPOSE

SKIN TREATMENT

USES

AGAINST ECZEMA, PIMPLES AND OTHER SKIN CONDITIONS. TREATMENT OF DERMATOPHYTE INFECTIONS.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

DO NOT APPLY TO EXUDATIVE WOUNDS.

AVOID CONTACT WITH EYES.

STOP USE AND ASK A DOCTOR IF

SYMPTOMS PERSIST

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

WASH THE AFFECT PART WITH WARM WATER AND SOAP.

APPLY THE OINMENT LIBERALLY IN THE MORNING AND EVENING.

OTHER INFORMATION

STORE AT TEMPERATURE NOT HIGHER THAN 86°F (30°C).

INACTIVE INGREDIENTS

TITANIUM DIOXIDE, KAOLIN, MENTHOL, MINERAL OIL, WHITE PETROLATUM.

BENZO DERMA. Package Label.Principal Display Panel (51945-4)

MENTOL CHINO CONCENTRATED. Package Label.Principal Display Panel (51945-4)

MENTOL CHINO FORTE. Package Label.Principal Display Panel (51945-4)

INGREDIENTS AND APPEARANCE

MENTOL CHINO CONCENTRATED 
methyl salicylate, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84058-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD)	0.45 g  in 100 g
CAMPHOR OIL (UNII: 75IZZ8Y727)	4 g  in 100 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.0003 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U)	80 g  in 100 g
CINNAMON OIL (UNII: E5GY4I6YCZ)	0.25 g  in 100 g
PHENOL (UNII: 339NCG44TV)	0.45 g  in 100 g
D&C BLUE NO. 4 (UNII: 0KSY80VYS3)	0.0013 g  in 100 g
PARAFFIN (UNII: I9O0E3H2ZE)	4 g  in 100 g

Product Characteristics
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84058-120-13	3 in 1 BOX	04/22/2024
1		10 g in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/22/2024

MENTOL CHINO FORTE 
methyl salicylate, menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84058-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	7 g  in 100 g
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727)	CAMPHOR OIL	5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD)	0.8 g  in 100 g
PHENOL (UNII: 339NCG44TV)	0.4 g  in 100 g
PARAFFIN (UNII: I9O0E3H2ZE)	4 g  in 100 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.0003 g  in 100 g
D&C BLUE NO. 4 (UNII: 0KSY80VYS3)	0.006 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U)	75 g  in 100 g
CINNAMON OIL (UNII: E5GY4I6YCZ)	0.3 g  in 100 g

Product Characteristics
Color	yellow (Light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84058-111-62	1 in 1 BOX, UNIT-DOSE	04/22/2024
1		60 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/22/2024

BENZO DERMA 
benzoic acid, salicylic acid, sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84058-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2.5 g  in 100 g
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM)	BENZOIC ACID	6 g  in 100 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	4.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)	1 g  in 100 g
KAOLIN (UNII: 24H4NWX5CO)	4 g  in 100 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4)	62.67 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	10 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP)	6.23 g  in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84058-130-01	3 in 1 BOX, UNIT-DOSE	04/22/2024
1		12.5 g in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	04/22/2024

Labeler - LABORATORIOS H.G. C.A. (935000562)

Registrant - LABORATORIOS H.G. C.A. (935000562)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIOS H.G. C.A.		935000562	manufacture(84058-120, 84058-111, 84058-130)