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Natureplex Hydrocortisone Hydro

Medically reviewed on November 30, 2017

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 Cream

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Antipruritic (anti-itch)

Uses
  • for the 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
  • and for external anal and genital itching

Warnings

For external use only.

Avoid contact with eyes.

Do Not Use
  • if you have a vaginal discharge. Consult a doctor.

When using this product
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put 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
  • beeding occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

For itching associated with minor skin irritations, 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: Consult a doctor

For external anal and genital itching:

Adults and children 12 years of age and older:

  • when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: Consult a doctor

Other information
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Natureplex™
MAXIMUM STRENGTH

Hydrocortisone Cream

Fast Itch And Rash Relief!

NET WT. 1 Oz. (28g)

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 (ALLYL PENTAERYTHRITOL CROSSLINKED) 
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(67234-010)

 
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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