ITCH-X- pramoxine hcl/benzyl alcohol spray 
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 Spray

Active ingredients.............. Purpose
(in solution)
Benzyl alcohol 10%............Topical analgesic
Pramoxine HCl 1%..............Topical analgesic

Uses temporarily relieves pain and itching associ- ated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac.

Uses temporarily relieves pain and itching associ- ated 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.
Keep away
from fire or flame.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a physician.

Do not apply to open wounds, damaged, or blistered skin.

Do not use for vaginal, genital, or rectal itching.

Do not use on children under 2 years of age unless under the advice and supervision of a physician.

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

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

Directions

Other information


Inactive ingredients aloe barbadensis (aloe vera gel), SD alcohol 40, and water

Questions?

1-800-324-1880, 7:30am - 4:00pm Central, Mon. - Fri., or visit www.bfascher.com

Itch-X Spray PDP

Itch-X Spray PDP

ITCH-X 
pramoxine hcl/benzyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0225-0516
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0225-0516-5159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/19/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/19/201410/31/2025
Labeler - BF ASCHER AND CO INC (003854403)

Revised: 11/2022
Document Id: ec8208ae-21d5-51d7-e053-2a95a90ad50d
Set id: 03f85dbb-a13a-3126-e054-00144ff8d46c
Version: 3
Effective Time: 20221102
 
BF ASCHER AND CO INC