Anti Itch Topical Analgesic
FDA Label NDC 63868-218

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Associations Inc for the product Anti Itch Topical Analgesic (NDC 63868-218). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Warnings

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Indications & Usage

→ Storage And Handling

→ Inactive Ingredient

→ Dosage & Administration

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredients Purpose

Diphenhydramine hydrochloride USP, 2%...................................... Antihistamine

Zinc acetate, 0.1%.................................................................... Skin protectant

Otc - Purpose

Uses

for the temporary relief of itching and pain associated with minor skin irritations and rashes due to insect bites, 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

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor before use

on chicken pox
on measles

Otc - When Using

When using this product avoid contact with the eyes

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

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

Indications & Usage

Directions

do not use more than directed
adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily, or as directed by a doctor
children under 12 years of age, consult a doctor