Monistat soothing care itch relief cream

Spl unclassified section

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

Otc - keep out of reach of children section

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.

Ingredients and appearance - Product information

Monistat soothing care itch relief cream- Hydrocortisone

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 30014-031
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydrocortisone ( UNII: WI4X0X7BPJ)( Hydrocortisone - UNII: WI4X0X7BPJ ) 10 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Ceteareth-6 ( UNII: 2RJS3559D3)
Cetyl alcohol ( UNII: 936JST6JCN)
Citric acid monohydrate ( UNII: 2968PHW8QP)
Dimethicone ( UNII: 92RU3N3Y1O)
Edetate disodium ( UNII: 7FLD91C86K)
Ethylparaben ( UNII: 14255EXE39)
Glycerin ( UNII: PDC6A3C0OX)
Methylparaben ( UNII: A2I8C7HI9T)
Mineral oil ( UNII: T5L8T28FGP)
Petrolatum ( UNII: 4T6H12BN9U)
Phenoxyethanol ( UNII: HIE492ZZ3T)
Propylparaben ( UNII: Z8IX2SC1OH)
Sodium citrate ( UNII: 1Q73Q2JULR)
Sodium hydroxide ( UNII: 55X04QC32I)
Stearyl alcohol ( UNII: 2KR89I4H1Y)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part348 USA

Labeler - McNEIL-PPC, Inc.( 801375143)

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)