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Anti-Itch by Dolgencorp, Inc.

Medically reviewed on Jul 2, 2018

Dosage form: cream
Ingredients: MENTHOL 1g in 100g, PRAMOXINE HYDROCHLORIDE 1g in 100g
Labeler: Dolgencorp, Inc.
NDC Code: 55910-407

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.

Anti-Itch

Active ingredients

Menthol 1%

Pramoxine hydrochloride 1%

Purpose

Anti-itch, Pain relief

Uses

for temporary relief of pain and itching associated with:

  • minor skin irritations
  • minor cuts
  • minor burns
  • rashes due to poison ivy, poison oak or poison sumac
  • scrapes
  • insect bites

Warnings

For external use only

Do not use on

  • deep or puncture wounds
  • animals bites
  • serious burns
  • large areas of the body

When using this product

  • do not get into eyes or nose
  • not for prolonged use

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • if redness, irritation, swelling or pain persists or increases

Keep out of reach of children.

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

Directions

adults and children 2 years and older: apply to affected area up to 3 or 4 times daily

children under 2 years: consult a doctor

Inactive ingredients

aloe vera (aloe barbadensis) leaf juice, diazolidinyl urea, disodium EDTA, eucalyptol, iodopropynyl butylcarbamate, methyl salicylate, mineral oil (parraffinum liquidum), petrolatum, PPG-1 trideceth-6, propylene glycol, sodium acrylates copolymer, steareth-21, stearyl alcohol, thymol,   tocopheryl acetate (vitamin E), triethanolamine, water

Other information

  • store at room temperature
  • for lot no. and exp. date, see crimp of tube or see box

PRINCIPAL DISPLAY PANEL

ANTI-ITCH CREAM

NET WT 1 OZ (28 g)

ANTI-ITCH 
menthol and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-407
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1 g  in 100 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
DIAZOLIDINYL UREA 
EDETATE DISODIUM 
EUCALYPTOL 
IODOPROPYNYL BUTYLCARBAMATE 
METHYL SALICYLATE 
MINERAL OIL 
PETROLATUM 
PPG-1 TRIDECETH-6 
PROPYLENE GLYCOL 
STEARETH-21 
STEARYL ALCOHOL 
THYMOL 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:55910-407-0328 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/30/2016
Labeler - Dolgencorp, Inc. (068331990)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(55910-407)

 
Dolgencorp, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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