Hydrocortisone by Dynarex Corporation / Galentic Pharma (India) Pvt. Ltd. HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation, Galentic Pharma (India) Pvt. 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

For temporary relief of:

• minor skin irritations

Itches and rashes due to:

• eczema
• insect bites
• poison ivy
• poison oak
• poison sumac
• soaps
• detergents
• cosmetics
• jewelry

and for external itching of:

• 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 physician if:

• the condition persists or gets worse
• symptoms clear up and appear again within a few days
• you are pregnant or breast feeding

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:

• apply evenly to affected area no more than 3 or 4 times daily.

Children under 2 years of age:

• Do not use
• consult a physician

Adults:

• when practical, 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
• apply externally to the area up to 6 times daily or after each bowel movement

​

INACTIVE INGREDIENT

Inactive ingredients:

Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, edetate disodium, liquid paraffin, propylene glycol, sodium betabisulphate, white soft paraffin, water (purified)

SPL UNCLASSIFIED SECTION

Other information:

• store at 20 deg. to 25 deg. C (68 deg. - 77 deg. F)
• avoid excessive heat and humidity

INDICATIONS & USAGE

For temporary relief of minor skin irritations and external itching.

PRINCIPAL DISPLAY PANEL

Principal Display Panel

Dynarex Hydrocortisone Items 1137 and 1139

Hydro1139.jpg

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-415
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)
ceteth-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-415-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	12/02/2015
2	NDC: 67777-415-02	0.9 g in 1 PACKET; Type 0: Not a Combination Product	12/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/02/2015

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Pvt. Ltd.		650970176	manufacture(67777-415)