Pain Relieveing Gel-patch
FDA Label NDC 84008-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bullet Point Llc for the product Pain Relieveing Gel-patch (NDC 84008-001). 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 dosage & administration, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Dosage & Administration

→ Warnings

→ Inactive Ingredient

→ Indications & Usage

→ Otc - Keep Out Of Reach Of Children

→ Otc - Purpose

→ Package Label.principal Display Panel

Dosage & Administration

Adults and children 12 years old and over:

Clean and dry the affected area.
Apply 1 patch to the affected area.
Do not exceed 1 patch at a time.
Leave in place for up to 8 hours.
Do not use more than 1 patch in 24 hours unless directed by a doctor.

Children under 12 years old: ask a doctor.

Warnings

For external use only

Inactive Ingredient

Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Indications & Usage

For temporary relief of pain.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control.

Otc - Purpose

Topical anesthetic.

* Please review the disclaimer below.

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