ACNE TREATMENT- dermaline sulfur ointment

Acne Treatment by

Drug Labeling and Warnings

Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Dermaline USA corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sulfur Precipitated 10%....... Acne Medication

WHEN USING

Uses:

For the treatment of acne. Penetrates the pores and dries and clears pimples and blackheads. Helps to keep new pimples and blackheads from forming.

KEEP OUT OF REACH OF CHILDREN

Warnings: External Use Only. Keep out of reach of children.

Avoid direct contact with eyes. In case of eye contact, flush thoroughly with water. Discontinue use if irritation occurs.

DO NOT USE

Do not use on wounds or damaged skin, with a bandage, with heating pad, over extensive areas of the body, on children under 16 years of age unless directed by a doctor. If pregnant or breast-feeding ask a health professional before use. In case of accidental ingestion, get medical help or contact a Poison Control center immediately.

WHEN USING

Adults and children 16 years of age and older. Wash th affected area with mild soap and warm water and rinse thorougly. Apply to affected area not more than 3 to 4 times daily. Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age: consult a doctor.

INACTIVE INGREDIENT

Cetyl/Stearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Polyethyleneglycol, Propyleneglycol, Propylparaben, Sorbitan Oleate, Water

OTHER SAFETY INFORMATION

Store at controlled room temperature: 15- 30 degrees C (59-86 degree F). Do not expose to excessive heat.

QUESTIONS

Questions? Dermaline USA, 1(800) 371-0171 Weekdays 9am to 4pm. Eastern

DOSAGE & ADMINISTRATION

Adults and children 16 years of age and older. Wash th affected area with mild soap and warm water and rinse thorougly. Apply to affected area not more than 3 to 4 times daily. Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age: consult a doctor.

WARNINGS

Warnings: External Use Only. Keep out of reach of children.

Avoid direct contact with eyes. In case of eye contact, flush thoroughly with water. Discontinue use if irritation occurs.

INDICATIONS & USAGE

Uses:

For the treatment of acne. Penetrates the pores and dries and clears pimples and blackheads. Helps to keep new pimples and blackheads from forming.

PURPOSE

Acne Medication

PRINCIPAL DISPLAY PANEL

Label

INGREDIENTS AND APPEARANCE

ACNE TREATMENT 
dermaline sulfur ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82165-108
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLENE GLYCOL 2-PALMITATE (UNII: PD789E82CQ)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82165-108-02	70.9 g in 1 JAR; Type 0: Not a Combination Product	04/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	04/15/2022

Labeler - Dermaline USA corp (016069241)