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Monistat Soothing Care Itch Relief

Dosage form: cream
Ingredients: Hydrocortisone 10mg in 1g
Labeler: McNEIL-PPC, Inc.
NDC Code: 30014-031

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.

Monistat® Soothing Care® Itch Relief Cream

Drug Facts

Active ingredient (in each applicator)

Hydrocortisone 1%

Purpose

Anti-Itch

Uses
  • temporarily relieves external 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
  • if you have 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 directed by a doctor

Stop use and ask a doctor if
  • condition worsens , or if 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

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

Directions
  • adults: apply to affected area not more than 3-4 times daily.
  • children under 12 years of age, ask a doctor

Other information
  • store at room temperature. Protect from freezing and excessive heat.

Inactive ingredients

ammonium acryloyldimethyltaurate/VP copolymer, carbomer, ceteareth-6, cetyl alcohol, citric acid, dimethicone, disodium EDTA, ethylparaben, glycerin, methylparaben, mineral oil, petrolatum, phenoxyethanol, propylparaben, sodium citrate, sodium hydroxide, stearyl alcohol, VP/eicosene copolymer, water.

PRINCIPAL DISPLAY PANEL - 28g Tube Carton

Anti-Itch Plus
Healing formula

FROM THE MAKERS OF

MONISTAT®

SOOTHING CARE®

New!
ITCH RELIEF
CREAM
Maximum Strength

  • Instantly Relieves
    Burning Itch

  • Helps Heal
    Irritated Skin

  • Long-Lasting

1% Hydrocortisone
Fragrance Free
NET WT. 1 OZ. (28g)

MONISTAT   SOOTHING CARE ITCH RELIEF
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30014-031
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Ceteareth-6 
Cetyl Alcohol 
Citric Acid Monohydrate 
Dimethicone 
Edetate Disodium 
Ethylparaben 
Glycerin 
Methylparaben 
Mineral Oil 
Petrolatum 
Phenoxyethanol 
Propylparaben 
Sodium Citrate 
Sodium Hydroxide 
Stearyl Alcohol 
Water 
Packaging
#Item CodePackage Description
1NDC:30014-031-011 TUBE (TUBE) in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/11/2011
Labeler - McNEIL-PPC, Inc. (801375143)

Revised: 10/2011
Document Id: cde1de51-22fe-4c5e-9fd4-919f7c6e5164
Set id: 83ac61b9-f52a-4f35-84d6-36b750b3278a
Version: 1
Effective Time: 20111012
 
McNEIL-PPC, Inc.

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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