Vitamin A And D Ointment
FDA Label NDC 55319-103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services Inc for the product Vitamin A And D (NDC 55319-103). 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, indications & usage, warnings, otc - when using, otc - stop use, otc - do not 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

Active Ingredients

Lanolin         15.5%

Petrolatum   53.4%

Otc - Purpose

Purpose

Diaper Rash Ointment

Skin Protectant

Indications & Usage

Uses

Helps prevent diaper rash. Temporarily protects minor cuts, scrapes and burns. Temporarily protects and helps relieve chapped, chafed or cracked skin. Helps protect chafed skin due to diaper rash and helps seal out wetness.

Warnings

Warnings

For external use only.

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask doctor if condition worsens or symptoms last more than 7 days. If swallowed, get medical help or contact a poison control center immediately.

Otc - Do Not Use

Do not use on deep or puncture wounds, animal bites or serious burns.

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 (1-800-222-1222).

Dosage & Administration

Direction

Apply as needed to dry or irritated skin. If using for diaper changes, gently clean diaper area and allow to dry. Apply cream liberally with each diaper change and as often as desired.

Storage And Handling

Other Information

Store at 20°C to 25°C (68°F to 77°F). Do not use if seal under cap on tube is broken, missing or if tube tip is cut prior to opening. Store upright when not in use.

Inactive Ingredient

Inactive Ingredients

Cod liver oil (contains vitamin A&D), fragrance, light mineral oil, microcrystalline wax, paraffin

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