DERMEND MOISTURIZING ANTI-ITCH- pramoxine hydrochloride lotion 
Ferndale Laboratories, 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.

----------

DerMend Moisturizing Anti-Itch Lotion

Active ingredient

Pramoxine HCl 1% w/w

Purpose

external analgesic

Use

for the temporary relief of itching associated with minor skin irritations

Warnings

For external use only.

Avoid contact with the eyes.

Stop use and ask a doctor if

  • conditions worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, seek medical attention or contact a Poison Cotrol Center right away.

Directions

Inactive ingredients

cetyl alcohol, di-isopropyl adipate, dimethicone, glycerin, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), mineral oil, polyoxyl 40 stearate, potassium sorbate, povidone, purified water, sorbic acid, stearic acid, and trolamine

Package Label

NDC 0496-0586-08

8oz (237mL)

DerMendBottleLabel

DERMEND MOISTURIZING ANTI-ITCH 
pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0586
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SORBIC ACID (UNII: X045WJ989B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0496-0586-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2017
Labeler - Ferndale Laboratories, Inc. (005320536)
Establishment
NameAddressID/FEIBusiness Operations
Ferndale Laboratories, Inc.005320536manufacture(0496-0586)

Revised: 2/2017
Document Id: 48814a87-ee9c-2e5b-e054-00144ff8d46c
Set id: 14c7fb1c-a310-4b12-ab2e-7f1c0801995c
Version: 1
Effective Time: 20170214
 
Ferndale Laboratories, Inc.