Dr.oh Patch
FDA Label NDC 76163-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yepharm for the product Dr.oh Patch (NDC 76163-010). 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, inactive ingredient, otc - purpose, warnings, otc - when using, otc - do not use, otc - stop use, otc - ask doctor, 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: CAMPHOR (NATURAL) 1.42%, MENTHOL 0.8%

Inactive Ingredient

Inactive ingredients:

Eucalyptus globulus leaf oil, Thymol, castor oil, dodecanal, citronellol, geraniol, citronellal, cymbopogon nardus oil, benzophenone, phenoxybenzene, benzyl benzoate

Otc - Purpose

Purpose:

Topical analgesic

Warnings

Warnings:

For external use only.

Otc - When Using

When using this product
- use only as directed.
- do not bandage tightly or use with a heating pad.
- do not use on irritated, wounded or damaged skin.
- avoid contact with eye or mucous membranes.

Otc - Do Not Use

Do not use if

- you are allergic to fragrance.
- you have asthma.
- you are pregnant or breast-feeding.

Otc - Stop Use

Stop use if
- condition worsens or symptoms persist for more than 7days.
- redness is present.
- irritation develops.

Otc - Ask Doctor

Ask a doctor if
- condition worsens or symptoms persist for more than 7days.
- redness is present.
- irritation develops.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children:

If patch is swallowed, get medical help or contact poison control center immediately.

Indications & Usage

Indication and usage:

Adults and children over 12 years
- use only as directed.
- do not use on children under 12 years of age.
- use up to 8 hours, repeat once if necessary.
- reseal pouch containing unused patches.

Storage And Handling

Storage:

Store in a cool and dry location out of direct sunlight.

Dosage & Administration

Dosage and administration:

Use up to 8 hours, repeat once if necessary.

* Please review the disclaimer below.