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NDC 00496-0586-08 DerMend Moisturizing Anti-Itch 10 mg/mL Details

DerMend Moisturizing Anti-Itch 10 mg/mL

DerMend Moisturizing Anti-Itch is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Ferndale Laboratories, Inc.. The primary component is PRAMOXINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 00496-0586-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	00496-0586
Product ID	0496-0586_48814a87-ee9c-2e5b-e054-00144ff8d46c
Associated GPIs	90850065104110
GCN Sequence Number	007423
GCN Sequence Number Description	pramoxine HCl LOTION 1 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	30520
HICL Sequence Number	002977
HICL Sequence Number Description	PRAMOXINE HCL
Brand/Generic	Brand
Proprietary Name	DerMend Moisturizing Anti-Itch
Proprietary Name Suffix	n/a
Non-Proprietary Name	pramoxine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	PRAMOXINE HYDROCHLORIDE
Labeler Name	Ferndale Laboratories, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00496-0586-08 (00496058608)

Pricing Information	N/A
NDC Package Code	0496-0586-08
Billing NDC	00496058608
Package	237 mL in 1 BOTTLE (0496-0586-08)
Marketing Start Date	2017-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 14c7fb1c-a310-4b12-ab2e-7f1c0801995c Details

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)

INGREDIENTS AND APPEARANCE

DERMEND MOISTURIZING ANTI-ITCH

pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0496-0586
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0496-0586-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/01/2017

Labeler - Ferndale Laboratories, Inc. (005320536)

Name	Address	ID/FEI	Business Operations
Establishment
Ferndale Laboratories, Inc.		005320536	manufacture(0496-0586)

Revised: 2/2017

Document Id: 48814a87-ee9c-2e5b-e054-00144ff8d46c

Set id: 14c7fb1c-a310-4b12-ab2e-7f1c0801995c

Version: 1

Effective Time: 20170214