DERMOSCRIBE SEBORRHEIC DERMATITIS- sulfur, salicylic acid, hydrocortisone cream
DERMOSCRIBE PTY LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DERMOSCRIBE (as PLD) - SEBORRHEIC DERMATITIS CREAM (69683-202)

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.

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

STORE AT ROOM TEMPERATURE

01b LBL_Seb Dermatitis Tube Label 113mm x 89mm FINAL ARTWORK

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
WATER (UNII: 059QF0KO0R)

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

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

Labeler - DERMOSCRIBE PTY LTD (742164734)