Assured Ice Cold Topical Analgesic
FDA Label NDC 33992-7994

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International, Inc. for the product Assured Ice Cold Topical Analgesic (NDC 33992-7994). 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, uses, warnings, when using this product do not, consult a doctor and discontinue use, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ When Using This Product Do Not

→ Consult A Doctor And Discontinue Use

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package Label.principal Display Panel

→ Assured Ice Cold Topical Analgesic Gel 8oz (33992-7994-8)

Active Ingredient

Menthol 1.25%

Purpose

Topical Analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with

smoking
excessive phlegm
asthma
emphysema
persistent or chronic cough

When Using This Product Do Not

heat
microwave
add to hot water or any container where healing water may cause splattering and result in burns
use in eyes or directly on mucous membranes
take by mouth or place in nostrils
apply to wounds or damaged skin
bandage skin

Consult A Doctor And Discontinue Use

if condition worsens, persist for more than 1 week or tends to recur

Keep Out Of Reach Of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

see important warnings under "When using this product"
adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
children under 2 years of age: consult a physician.