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ANTI-ITCH FEMININE CARE

Dosage form: cream
Ingredients: HYDROCORTISONE 5mg in 1g
Labeler: OHIO LAB PHARMA
NDC Code: 70648-103

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.

ACTIVE INGREDIENT

Hydrocortisone, USP 0.5%

PURPOSE

Anti-itch

USES

For temporary external feminine itching

WARNINGS

For External Use Only

Avoid Contact with eyes

DIRETIONS

Adults and children 12 years and older Apply to external vaginal area not more than 3 to 4 times a day
Children under 12 years Consult a doctor

DO NOT USE IF

you have a vaginal discharge. Consult a physician.

KEEP OUT OF REACH OF CHILDREN

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

OTHER INFORMATION
  • store at 20°-25°C (68°-77°F)

INACTIVE INGREDIENT

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, decyl oleate, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

QUESTIONS

www.ohiolabpharma.us

PACKAGE LABEL

NET WT 1OZ (20G)

HYDROCORTISONE0.5%

ANTI-ITCH FEMININE CARE 
hydrocortisone 0.5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70648-103
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
PROPYLPARABEN 
.ALPHA.-TOCOPHEROL 
METHYLPARABEN 
EDETATE DISODIUM 
CETEARETH-12 
WATER 
STEARIC ACID 
SODIUM CETOSTEARYL SULFATE 
CETOSTEARYL ALCOHOL 
OCTYLDODECANOL 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:70648-103-011 TUBE in 1 CARTON
120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2017
Labeler - OHIO LAB PHARMA (080215854)
Registrant - OHIO LAB PHARMA (080215854)
Establishment
NameAddressID/FEIOperations
OHIO LAB PHARMA080215854manufacture(70648-103)

Revised: 11/2017
 
OHIO LAB PHARMA

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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