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ITCH X by BF ASCHER AND CO INC

Dosage form: gel
Ingredients: BENZYL ALCOHOL 10g in 100g, PRAMOXINE HYDROCHLORIDE 1g in 100g
Labeler: BF ASCHER AND CO INC
NDC Code: 0225-0495

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.

Itch-X Gel

Active ingredients......................................Purpose

Benzyl alcohol 10%......................................Topical analgesic
Pramoxine hydrochloride 1%.......................Topical analgesic

Use

For temporarily relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac.

Use

Temporarily relieves pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac

Warnings

  • For external use only.
  • Avoid contact with eyes.

Do not use

  • on open wounds, damaged, or blistered skin.
  • for vaginal, genital, or rectal itching.
  • on children under 2 years of age unless under the advice and supervision of a physician.

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.

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

Keep this and all drugs out of reach of children. In case of ingestion, get medical help or contact a poison control center immediately.

Directions

  • adults and children 2 years and older - apply to affected area not more than 3 or 4 times daily
  • children under 2 years - consult a physician

Other information

  • store at 59°-86° F (15°-30° C) in a dry place
  • mfd. in the USA for B.F. Ascher & Co., Inc.

Inactive ingredients: aloe barbadensis leaf juice (aloe vera gel), blue 1, butylene glycol, carbomer, diazolidinyl urea, methylparaben, propylene glycol, propylparaben, SD alcohol 40, styrene/acrylates copolymer, tetrahydroxypropyl ethylenediamine, and water

Questions? Call 1-800-324-1880, 7:30am - 4:00pm Central, M - F, or visit www.bfascher.com

Itch-X Gel PDP

ITCH X 
benzyl alcohol/pramoxine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0225-0495
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZYL ALCOHOL (BENZYL ALCOHOL) BENZYL ALCOHOL10 g  in 100 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL 
ALCOHOL 
ALOE 
WATER 
EDETOL 
PROPYLENE GLYCOL 
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PROPYLPARABEN 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:0225-0495-3335.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/19/2014
Labeler - BF ASCHER AND CO INC (003854403)

Revised: 09/2014
 
BF ASCHER AND CO INC

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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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