RxNorm Names

Review RxNorm Normal Forms

ANTI-ITCH (diphenhydramine hcl) gel
[Navarro Discount Pharmacies,LLC]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=dd87c157-353f-4601-adc2-3913f21544a7

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active ingredients (in each gram)

Diphenhydramine HCl 2%

Purposes

Topical analgesic

Skin protectant

Uses

temporarily relieves itching and pain associated with insect bites, minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Warnings

For external use only

Do not use

on chicken pox or measles
with any other product containing diphenhydramine, even one taken by mouth
on large areas of the body, including large areas of poison ivy, sunburn, or broken, blistered or oozing skin

Stop use and ask a doctor if

condition worsens or does not improve within 7 days
symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

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

Directions

adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor
do not use more often than directed

Other information

store at 15°-25°C (59°-77°F)

Inactive ingredients

camphor, citric acid, ethanol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Package label

Anti-Itch Gel

ANTI-ITCH
diphenhydramine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59970-076
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC)
CITRIC ACID MONOHYDRATE
ALCOHOL
GLYCERIN
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE

Packaging
#	Item Code	Package Description
1	NDC:59970-076-01	113 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	01/18/2013

Labeler - Navarro Discount Pharmacies,LLC (094930963)

Revised: 01/2013

Document Id: 1ba70839-f441-46ed-90e6-007a5d1606d3

Set id: dd87c157-353f-4601-adc2-3913f21544a7

Version: 1

Effective Time: 20130118

Navarro Discount Pharmacies,LLC

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