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Name:Berkley And Jensen Hydrocortisone
Manufacturer:Bjwc
Category:Over-the-counter (OTC) Marketed Drugs


BJWC Hydrocortisone 1% Cream Drug Facts

BERKLEY AND JENSEN HYDROCORTISONE - hydrocortisone cream 
BJWC

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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BJWC Hydrocortisone 1% Cream Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, 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. Ask a doctor.
  • for the treatment of diaper rash. Ask a doctor.

When using this product

  • avoid contact with the 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.

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

Directions

  • for itching of 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: do not use, 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

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water

Questions or comments?

1-800-934-1204

Principal Display Panel

Maximum Strength

Hydrocortisone 1% Cream

Anti-Itch Cream

Hydrocortisone 1% Cream Carton

Hydrocortisone 1% Cream Carton


BERKLEY AND JENSEN HYDROCORTISONE 
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-319
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g  in 100 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68391-319-26 2 TUBE ( TUBE) in 1 CARTON contains a TUBE (68391-319-16)
1 NDC:68391-319-16 56 g in 1 TUBE This package is contained within the CARTON (68391-319-26)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/04/2008

Labeler - BJWC (159082692)

Revised: 07/2009 BJWC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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