ITCH X- benzyl alcohol/pramoxine hydrochloride gel 
BF ASCHER AND CO INC

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.

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Itch-X Gel

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

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

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

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

Do not use

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.

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

Other information

Inactive ingredients: aloe barbadensis leaf juice (aloe vera gel), blue 1, butylene glycol, carbomer, citric acid, diazolidinyl urea, iodopropynyl butylcarbamate, potassium sorbate, SD alcohol 40, sodium benzoate, sodium sulfite, styrene/acrylates copolymer, tetrahydroxypropyl ethylenediamine, and water

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

Itch-X Gel PDP

Itch-X Gel PDP

ITCH X 
benzyl alcohol/pramoxine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0225-0495
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL10 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALCOHOL (UNII: 3K9958V90M)  
ALOE (UNII: V5VD430YW9)  
WATER (UNII: 059QF0KO0R)  
EDETOL (UNII: Q4R969U9FR)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
STYRENE/AMMONIUM ACRYLATE COPOLYMER (300000 MW) (UNII: PA4J9TF5U2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0225-0495-3335.4 g in 1 TUBE; Type 0: Not a Combination Product09/19/2014
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: 11/2022
Document Id: ec8208ae-21d1-51d7-e053-2a95a90ad50d
Set id: 03c16d33-8f59-0184-e054-00144ff8d46c
Version: 5
Effective Time: 20221102
 
BF ASCHER AND CO INC