HYDROCORTISONE CREAM 1% cream

Hydrocortisone Cream 1% by

Drug Labeling and Warnings

Hydrocortisone Cream 1% by is a Otc medication manufactured, distributed, or labeled by SOLA Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Purpose

Antipruritic (Anti-itch)

Uses

Relieves itches and rashes due to:

• Eczema
• Psoriasis
• Seborrheic dermatitis
• Poison ivy
• Poison oak
• Poison sumac
• Insect bites
• External anal itching
• Soaps
• Detergents
• Cosmetics
• Jewelry

Temporary relief of external anal and genital itching.

Other use of the product should only be under the advice and supervision of a doctor.

Warnings

For external use only

Do not use:

• In the eyes
• For diaper rash
• If you have vaginal discharge
• More than the recommended dosage

Ask doctor before use:

• If you are pregnant or breast feeding

Stop use and ask a doctor if:

• Condition worsens, or is 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.

​When using this product:

• Do not put this product into rectum by using fingers or any mechanical device or applicator.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Directions

• Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day.
• Children under 2 years of age - Do not use. Consult a doctor.
  • For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. ​Apply to affected area not more than 3-4 times per day. Children under 12 years of age: consult a doctor.

Other Information

• store between 20ºC and 25ºC (68ºFk and 77ºF)
• avoid excessive heat and humidity

Inactive Ingredients

Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Disodium EDTA, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphite, White soft paraffin.

PRINCIPAL DISPLAY PANEL

Questions of comments? Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals

Baton Rouge, LA 70810

Store in a dry, cool place

Hydrocortisone 1% Cream

NDC: 70512-101-30

Qty: 28.4g

INGREDIENTS AND APPEARANCE

HYDROCORTISONE CREAM 1% 
hydrocortisone cream 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70512-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CHLOROCRESOL (UNII: 36W53O7109)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
CETETH-20 (UNII: I835H2IHHX)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70512-101-30	1 in 1 CARTON	04/16/2020
1		30 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 not final	part348	04/16/2020

Labeler - SOLA Pharmaceuticals (080121345)