Atopalm Itch Relief
FDA Label NDC 51141-400

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neopharm Co, Ltd for the product Atopalm Itch Relief (NDC 51141-400). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings:, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Diphenhydramine HCl 2%

Zinc Acetate 0.1%

Purpose

Topical Analgesic

Skin protectant

Uses

For the temporary relief of itching and pain associated with
insect bites
minor burns
sunburn
minor skin irritations
minor cuts
scrapes
rashes due to poison ivy, poison oak and poison sumac
dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Warnings:

For external use only.

Do Not Use

on large areas of the body or with any other product containing Diphenhydramine, even one taken by mouth.

Ask a doctor before use on chicken pox or measles.

When Using This Product

avoid contact with the eyes

Stop Use And Ask A Doctor If

condition worsens or does not improve within 7 days, or if 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 immediately.

Directions

adults and children 2 years of age and older, apply to affected area no more than 3 to 4 times daily, or as directed by a doctor.
children under 2 years of age, consult a doctor.
do not use more often than directed

Other Information

store between 20C to 25C (69F to 77F)
see end of carton or tube crimp for lot number and expiration date.

Inactive Ingredients

Water, Glycerin, Cetyl Alcohol, Mineral Oil, Polysorbate 60, Stearic Acid, Glyceryl sterate, Carbomer 940, Cholesterol, Methylparaben, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, propylparaben.

Questions?

Call 1-855-ATOPALM

Package Label.Principal Display Panel

ATOPALM ITCH RELIEF CREAM

with US Patented MLE Technology


MAXIMUM STRENGTH THERAPY
TOPICAL ANALGESIC

HISTAMINE BLOCKER
SKIN PROTECTANT

For fast, temporary relief of pain and itching from insect bites and skin irritations from poison ivy, poison oak, and poison sumac, dries up poison ivy, poison oak, and poison sumac. Leaves skin looking visibly healthier, softer, smoother.

ATOPALM
Histamine Blocker
Topical Analgesic
Skin protectant

Net Wt. 1oz/28.3 g

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