Pinxav Daiper Rash Ointment
FDA Label NDC 82778-342

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Emjay Laboratories Inc. for the product Pinxav Daiper Rash (NDC 82778-342). 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 other, active ingredient, purpose, uses, warnings, 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

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ For Diaper Rash:

→ Inactive Ingredients

→ Questions Or Comments?

→ Package Label.principal Display Panel

→ Principal Display Panel - 4.0 Oz Tube

→ Principal Display Panel - 4.0 Oz Carton

Other

Drug Facts

Active Ingredient

Zinc oxide 30%

Purpose

Skin Protectant

Uses

helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only

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

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.

Directions

apply liberally as often as necessary

For Diaper Rash:

change wet or soiled diapers promptly
cleanse the diaper area and allow to dry
apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive Ingredients

Aloe Vera Gel, Aluminum Hydroxide, Cetyl Alcohol, Clove Leaf Oil, Eucayptol, Lanolin, Menthol, Methyl Salicylate, Petrolatum, Red Ferric Oxide, Stearic Acid, Tocopherol