REESES PINWORM ITCH RELIEF- pramoxine hydrochloride cloth 
Reese Pharmaceutical Co

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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Reeses PINWORM Itch Relief - Drug Facts Label

Active ingredient

Pramoxine Hydrochloride 1.0% w/w

Purpose

ANALGESIC

Uses

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Direction

Other information

Inactive ingredients

purified water, glycerin, propylene glycol, cocoamphodiacetate, polysorbate 20, aloe vera barbadensis leaf juice, citric acid, fragrance, diazolidinyl urea, iodopropynyl butylcarbamate.

Questions or comments?

1-800-321-7178

Images of representative packaging

image on carton

REESES  PINWORM ITCH RELIEF
pramoxine hydrochloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-799
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10956-799-2089 g in 1 PACKAGE; Type 0: Not a Combination Product10/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/21/2013
Labeler - Reese Pharmaceutical Co (004172052)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Guy & O'Neill, Inc.138513069manufacture(10956-799) , label(10956-799)

Revised: 10/2017
Document Id: 7d935f99-18bd-4d0d-93c1-cea254d12cb1
Set id: 9ee60214-2cda-43a2-8fc9-5ab78c01acaf
Version: 1
Effective Time: 20171002
 
Reese Pharmaceutical Co