SOFSKIN HYDROCORTISONE 1 PERCENT- hydrocortisone hcl cream

SOFSKIN HYDROCORTISONE 1 PERCENT by

Drug Labeling and Warnings

SOFSKIN HYDROCORTISONE 1 PERCENT by is a Otc medication manufactured, distributed, or labeled by GOPALDAS VISRAM AND COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

HYDROCORTISONE 1%

PURPOSE

Antipruritic (Anti-Itch)

USES

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema
• psoriasis
• poison ivy
• poison oak
• poison sumac
• insect bites
• detergents
• jewelry
• cosmetics
• soaps
• seborrheic dermatitis
• temporarily relieves external anal and genital itching
• other uses of this product should only be under the advice and supervision of a doctor

WARNINGS

• For external use only.

Do not use

• in the genital area if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Consult a doctor.

When using this product

• avoid contact with eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use
  of any other hydrocortisone product unless you have asked a doctor
• rectal bleeding occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

• for itching or skin irritation, inflammation, and rashes:
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor
• for external anal and genital itching, adults:
• when practical, clean the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying
• apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor

OTHER INFORMATION

• do not use if seal on the tube is damaged or is not visible
• to open, unscrew cap, pull tab to remove foil seal
• store at 20° to 25°C (68° to 77°F)
• avoid excessive heat and humidity
• see crimp of tube or carton for Lot Number and Expiry Date

INACTIVE INGREDIENT

Aloe Vera Extract, Cetostearyl Alcohol, Glyceryl Monostearate SE, Kathon CG, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOFSKIN HYDROCORTISONE 1 PERCENT 
hydrocortisone hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61040-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61040-129-11	1 in 1 BOX	07/15/2024
1	NDC: 61040-129-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/15/2024

Labeler - GOPALDAS VISRAM AND COMPANY LIMITED (858030888)