DERMOSCRIBE SEBORRHEIC DERMATITIS- sulfur, salicylic acid, hydrocortisone cream

DERMOSCRIBE SEBORRHEIC DERMATITIS by

Drug Labeling and Warnings

DERMOSCRIBE SEBORRHEIC DERMATITIS by is a Otc medication manufactured, distributed, or labeled by DERMOSCRIBE PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Sulfur 3%, Salicylic Acid 3%, Hydrocortisone 1%

PURPOSE

TREATMENT OF SEBORRHEIC DERMATITIS.

USE

Dermoscribe's Seborrheic Dermatitis Cream is a topical treatment for relief of the symptoms and signs of Seborrheic Dermatitis.

WARNINGS

FOR EXTERNAL USE ONLY. Avoid contact with mouth, eyes and anal skin.
Do not swallow. Seek medical advice before using if pregnant or breastfeeding. If irritation
develops, stop using and seek medical advice. May not be as effective after expiry date.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

For use only by persons over 12 years old. Apply in a thin layer over the affected area once or twice daily as required.

Use only in accordance with the directions on the label and within the packaging. Refer to enclosed leaflet for detailed directions.

INACTIVE INGREDIENTS

AQUEOUS CREAM

OTHER SAFETY INFORMATION

STORE AT ROOM TEMPERATURE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMOSCRIBE SEBORRHEIC DERMATITIS 
sulfur, salicylic acid, hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69683-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 g  in 100 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	3 g  in 100 g
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCOL STEARATE SE (UNII: 6YLY96TQL6)
SORBITOL (UNII: 506T60A25R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT OIL (UNII: Q9L0O73W7L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69683-202-11	60 g in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/23/2015

Labeler - DERMOSCRIBE PTY LTD (742164734)