Label: ITCH X- benzyl alcohol/pramoxine hydrochloride gel
- NDC Code(s): 0225-0495-33
- Packager: BF ASCHER AND CO INC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated November 2, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
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
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INGREDIENTS AND APPEARANCE
ITCH X
benzyl alcohol/pramoxine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0225-0495 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 10 g in 100 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 1 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0225-0495-33 35.4 g in 1 TUBE; Type 0: Not a Combination Product 09/19/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/19/2014 Labeler - BF ASCHER AND CO INC (003854403)