Eucalyptamint
FDA Label NDC 63736-340

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals for the product Eucalyptamint (NDC 63736-340). 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 - do not use, otc - when using, otc - stop use, 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 - Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions

→ Principal Display Panel - Tube Label

→ Principal Display Panel - Carton Label

Other

Drug Facts

Dist. by: INSIGHT Pharmaceuticals Corp., Langhorne, PA 19047-1749

63005H

Active Ingredient

Menthol 16%

Purpose

Topical Analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with:

arthritis
sore muscles
simple backache
strains
sprains

Warnings

For external use only

Otc - Do Not Use

Do not use

other than as directed
with a heating pad or heating device

Otc - When Using

When using this product

avoid contact with the eyes
do not bandage tightly
do not apply to wounds or damaged skin

Otc - Stop Use

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few 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

adults and children 2 years of age and older: gently massage a conservative amount into affected area not more than 3 to 4 times daily.
children under 2 years of age: consult a doctor
if thickening of product occurs, warm tube in palm of hand or run under warm water.