Shopko Medicated Lip Treatment
FDA Label NDC 37012-735

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shopko for the product Shopko Medicated Lip Treatment (NDC 37012-735). 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, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Camphor (1.70%), Menthol (0.70%)

Purpose

Analgesic, Anti-itch

Keep Out Of Reach Of Children

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

Uses

For the temporary relief of pain and itching associated with fever blisters and cold sores. Helps prevent and temporarily protects dry chapped lips.

Warnings

For external use only. When using this product: avoid contact with eyes. Rinse with water to remove. Stop use and ask a doctor if: rash or irritation develops and lasts for more than 7 days. Keep out of reach of children: if swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally and evenly. Reapply as needed.

Inactive Ingredients

Copernicia Cerifera (Carnauba) Wax, Flavor, Lanolin, Microcrystalline Wax, Mineral Oil, Ozokerite, Petrolatum, Phenol, Salicylic Acid, Theobroma Cacao (Cocoa) Seed Butter.

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