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NDC 68437-0010-01 Sulfur 10 g/100g Details

Sulfur 10 g/100g

Sulfur is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by GRISI Hnos, S.A DE C.V. The primary component is SULFUR.

Product Information

NDC	68437-0010
Product ID	68437-010_eb0475c6-c759-55a1-e053-2a95a90a69e9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Sulfur
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sulfur
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	g/100g
Substance Name	SULFUR
Labeler Name	GRISI Hnos, S.A DE C.V
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M006
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68437-0010-01 (68437001001)

Pricing Information	N/A
NDC Package Code	68437-010-01
Billing NDC	68437001001
Package	1 TUBE in 1 CARTON (68437-010-01) / 20 g in 1 TUBE (68437-010-20)
Marketing Start Date	2012-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f91be302-2df1-4e62-8cff-411949c2cef8 Details

Active Ingredients/Ingredientes Activos

Sulfur/Azufre10%

Purpose/Utilidad

Acne treatment/Tratamiento para el acné

Uses/Usos

■ For the treatment of acne/Para el uso del acne

■ Dries and clears acne pimples and allows skin to heal/seca y limpia las espinillas del acne y permite que la piel sane

■ Helps prevent new acne pimples from forming/ayuda a prevenir la nueva formación de espinillas del acne

Warnings/Precauciones

■ For external use only/Solo par uso externo

■ Not for children under 12 years/No par ninos menores de 12 anos

Do not use/No user en

■ Broken skin/Heridas abiertas

■ Large areas of the skin/Grandes superficies de piel

When using this product/Cuando use este producto

■ Skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If irritation occursuse only one topical acne medication at a time/Se pueda presentar irritación ylo resequedad en la piel si se usa al mismo tiempo medicamento para el acné al mismo tiempo otro medicamento para el acne. Si esto ocurre, use solo medicamento para el acné.

■ Apply only to the areas with acne/Aplique únicamente en áreas con acné

St op use and ask a doctor if/Suspenda su uso y consulte al medico si

■ if skin irritation occurs or gets worse, stop use and consult a physician/Aparece alguna irritacion en la piel o esta empeora, suspenda su uso y consulte a su medico.

Keep out of the reach of children

Mantengase fuera del alcance de los ninos

Directions/Modo de uso

■ Clean the skin thoroughly before applying this product/Limpiar bien la piel antes de aplicar el producto

■ Cover the entire affected area with a thin layer one to three times daily/Cubrir toda él área afecteda con una capa delgada una a tres veces al dia

■ Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor/Debido a que puede ocurrir un exceso de resequedad en la piel, comience con una aplicación al día e incremente de los a tres veces al dia cuando sea necesario o segun las indicaciones del médico

■ If bothersome dryness or peeling occurs, reduce application to once a day or every other day/Si aparece alguna resequedad o descamación, reduzca la aplicación a una vez al día o cada dos días

Inactive Ingredients/Ingredientes inactivos

BHT, Carbomer, Cetearyl Alcohol, Decyl olivate, DMDM Hydantoin, Fragrance, Isopropyl Myristate, Lanolin, Lanolin Alcohol, Menthol, Methylparaben, Mineral Oil, Oleyl Alcohol, Polysorbate 80, Propylene Glycol, Propylparaben, Sorbitan Palmitate, Triethanolamone, Water

Questions or comments/Dudas o comentarios

1-833-794-3320

Package Label

INGREDIENTS AND APPEARANCE

SULFUR

sulfur ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68437-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68437-010-01	1 in 1 CARTON	12/01/2012
1	NDC:68437-010-20	20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M006	12/01/2012

Labeler - GRISI Hnos, S.A DE C.V (810320754)

Name	Address	ID/FEI	Business Operations
Establishment
GRISI Hnos, S.A DE C.V		810320754	manufacture(68437-010)

Revised: 10/2022

Document Id: eb0475c6-c759-55a1-e053-2a95a90a69e9

Set id: f91be302-2df1-4e62-8cff-411949c2cef8

Version: 4

Effective Time: 20221014