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DerMend Moisturizing Anti-Itch

Medically reviewed on Feb 14, 2017

Dosage form: lotion
Ingredients: PRAMOXINE HYDROCHLORIDE 10mg in 1mL
Labeler: Ferndale Laboratories, Inc.
NDC Code: 0496-0586

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
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

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)

DERMEND MOISTURIZING ANTI-ITCH 
pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0586
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
DIISOPROPYL ADIPATE 
DIMETHICONE 
GLYCERIN 
PETROLATUM 
LANOLIN 
HYDROGENATED COCONUT OIL 
SORBITAN SESQUIOLEATE 
STEARYL ALCOHOL 
MINERAL OIL 
POLYOXYL 40 STEARATE 
POTASSIUM SORBATE 
POVIDONE 
WATER 
SORBIC ACID 
STEARIC ACID 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:0496-0586-08237 mL in 1 BOTTLE
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/FEIOperations
Ferndale Laboratories, Inc.005320536manufacture(0496-0586)

 
Ferndale Laboratories, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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