Diphenhydramine Hcl And Zinc Acetate Cream
FDA Label NDC 45802-358

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Padagis Israel Pharmaceuticals Ltd for the product Diphenhydramine Hcl And Zinc Acetate (NDC 45802-358). 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 ingredients, purpose, uses, warnings, do not use, ask a doctor before use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses

temporarily relieves pain and itching 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
with any other product containing diphenhydramine, even one taken by mouth

Ask A Doctor Before Use

on chicken pox
on 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
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

do not use more than directed
adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
children under 2 years of age: ask a doctor