Label: ITCH-X- pramoxine hcl/benzyl alcohol spray
- NDC Code(s): 0225-0516-51
- Packager: BF ASCHER AND CO INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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
- INDICATIONS & USAGE
- PURPOSE
- WARNINGS
- ASK DOCTOR
- DO NOT USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ITCH-X
pramoxine hcl/benzyl alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0225-0516 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 1 g in 100 mL BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 10 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE (UNII: V5VD430YW9) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0225-0516-51 59.1 mL in 1 BOTTLE, SPRAY; 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 10/31/2025 Labeler - BF ASCHER AND CO INC (003854403)