Natureplex Hydrocortisone Hydro

Dosage form: cream
Ingredients: Hydrocortisone 0.01g in 1g
Labeler: Natureplex, LLC
NDC Code: 67234-010

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.

HYDROCORTISONE LABEL

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 advise 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 another 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: ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or 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

  • contents filled by weight, not volume
  • Store between 15 and 30 C (59 and 86 F)
  • Do not use if seal on tube is punctured or missing


Inactive Ingredients

Aloe vera leaf, carbomer, cetyl alcohol, DMDM Hydantoin, glyceryl stearate, methylparaben, mineral oil, polysorbate 20, propylparaben, stearic acid, triethanolamine, trisodium edta, water

HYDROCORTISONE PACKAGE LABEL


NATUREPLEX HYDROCORTISONE  HYDRO
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf 
carbomer homopolymer type C 
cetyl alcohol 
DMDM Hydantoin 
glyceryl monostearate 
methylparaben 
mineral oil 
polysorbate 20 
propylparaben 
stearic acid 
trolamine 
edetate trisodium 
water 
alcohol 
Packaging
#Item CodePackage Description
1NDC:67234-010-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/22/2008
Labeler - Natureplex, LLC (062808196)
Establishment
NameAddressID/FEIOperations
Natureplex, LLC062808196manufacture

Revised: 02/2012
 
Natureplex, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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