Assured
FDA Label NDC 33992-1136

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 (NDC 33992-1136). 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, use, warnings, do not use, stop use if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320

Active Ingredient

Menthol 2.5%

Purpose

Topical Analgesic

Use

Temporarily relieves the minor aches and pains in muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only.

Avoid contact with the eyes or on mucous membranes.

Do Not Use

  • on wounds or damaged skin

Stop Use If

  • excessive irritation develops

Stop Use And Ask A Doctor If

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

When Using This Product

  • do not bandage or wrap tightly

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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: 800-222-1222.

Directions

  • Adults and children 2 years of age and older: apply to affected area up to 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor

Other Information

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients

Camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, purified water, sodium hydroxide

Questions Or Comments?

866-323-0107 or www.natureplex.com

Principal Display Panel - 42.5 G Tube Carton

ASSURED™

EXTRA STRENGTH PAIN RELIEVING GEL

Muscle Rub

Menthol 2.5%

Fast relief from:

  • Arthritis pain
  • Backache
  • Muscle pain
  • Joint pain

    • NET WT 1.5 OZ (42.5 g)

    Principal Display Panel (42.5 g Tube Carton)

    Principal Display Panel (42.5 g Tube Carton)

* Please review the disclaimer below.