Hydrocortisone by Dynarex Corporation / Gopaldas Visram & Co.,Ltd HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation, Gopaldas Visram & Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                  Purpose

Hydrocortisone 1%                              Antipruritic (anti-itch)

Warnings

​For external use only

Purpose

Uses: For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to, eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and external genital, feminine, and anal itching.

DO NOT USE

Do Not Use:

• in the eyes
• longer than 1 week unless directed by a physician
• for diaper rash
• if you have vaginal discharge
• more than recommended daily dosage unless directed by a doctor
• in the rectum using fingers or any other mechanical device or applicator

STOP USE

Stop use and ask a doctor if:

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, do not use this or any other hydrocortisone product.
• in case of bleeding when used for anal itching

KEEP OUT OF REACH OF CHILDREN

​ Keep Out Of Reach of Children

• if swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions:

Adults and children 2 years of age and older:

• apply evenly to affected area no more than 3 or 4 times daily. Children under 2 years of age consult a doctor

• when used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting and blotting with bathroom tissue or soft cloth before applying. Children under 12: consult doctor before using for anal itching.

​

INACTIVE INGREDIENT

Inactive ingredients:

Cetostearyl alcohol, glyceryl monostearate, methylchloroisothiazolinone, propylene glycol, purified water, stearic acid, trolamine, white soft paraffin 

SPL UNCLASSIFIED SECTION

Other information:

• store at room temperature
• avoid excessive heat

INDICATIONS & USAGE

For temporary relief of minor skin irritations and external itching.

PRINCIPAL DISPLAY PANEL

Principal Display Panel

Dynarex Hydrocortisone Items 1137 and 1139

Hydro 1139.jpg

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-417
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PARAFFIN (UNII: I9O0E3H2ZE)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-417-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	10/07/2016
2	NDC: 67777-417-02	0.9 g in 1 PACKET; Type 0: Not a Combination Product	10/07/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/07/2016

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Gopaldas Visram & Co.,Ltd		858030888	manufacture(67777-417)