Activon Ultra Strength
FDA Label NDC 51068-503

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family First Pharmaceuticals, Inc. for the product Activon Ultra Strength (NDC 51068-503). 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, do not use, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 5.138%

Purpose

Topical Analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with:
    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains

Warnings

For external use only.

Do Not Use

  • otherwise than as directed
  • if you are allergic to any ingredient in this product
  • on a child under 12 years of age with arthritis-like conditions
  • with a heating pad

When Using This Product

  • avoid contact with eyes, wounds, mucous membranes, broken or irritated skin
  • do not share this product with anyone
  • do not bandage tightly

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
  • skin redness or excessive irritation of the skin develops

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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • children under 12 years of age: ask a doctor

Other Information

Keep away from heat. Store between 15° and 30° C (59° and 86° F).

Inactive Ingredients

diazolidinyl urea, ethyl alcohol, iodopropynyl butylcarbamate, menthyl lactate, propylene glycol, sodium stearate, steareth-21, tetrasodium EDTA, triethanolamine, water

Questions ?

call 1-800-379-8870, Weekdays 9AM to 5PM EST
or visit us online at activ-on.com

Other

Dist. by Family First Pharmaceuticals, Inc., Reno, NV 89502

Principal Display Panel - 57 G Canister Carton

NEW
STRONGEST
ACTIVON® JOINT & MUSCLE

ACTIVON®
Topical Analgesic

ULTRA
STRENGTH
JOINT & MUSCLE

Powerful Pain Relief
for Joint & Muscle Pain,
Backache and More

No-Mess

NDC 51068-503-01
NET WT 2 OZ (57 g)

Principal Display Panel (57 g Canister Carton)

Principal Display Panel (57 g Canister Carton)

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