ActivOn Ultra Strength

Manufacturer
Family First Pharmaceuticals, Inc. | CPC Laboratories Inc.
Effective date
2011-06-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:29:27

Label at a glance#

ProductActivOn Ultra Strength Joint and Muscle
Active ingredientMenthol
Label structure11 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.138%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions ?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 57 g Canister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148640ActivOn Ultra Strength Joint & Muscle 5.138 % Topical CreamPSN2
1148638menthol 5.14 % Topical CreamPSN2
1148640menthol 51.4 MG/ML Topical Cream [ActivOn Joint & Muscle]SBD2
1148638menthol 51.4 MG/ML Topical CreamSCD2
1148640ActivOn Joint & Muscle 51.4 MG/ML Topical CreamSY2
1148640ActivOn Ultra Strength Joint & Muscle 5.138 % Topical CreamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51068-503-012019-10-29C16284748780-1960f7f55-da24-8e05-e053-dbdaa90a074aACTIV ON ® Topical Analgesic ULTRA STRENGTH JOINT & MUSCLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51068-503-01ActivOn Ultra StrengthJoint and Muscle1 in 1 CARTONSTICK12
51068-503-01ActivOn Ultra StrengthJoint and Muscle57 g in 1 CANISTERSTICK572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51068-503ACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2Legacy NDC, 2 package rows20110906_cdf0a374-2a2c-4e79-94f5-23746084d5e1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3A2
MentholACTIVE MOIETYL7T10EIP3A2
alcoholINACTIVE INGREDIENT3K9958V90M2
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW42
Edetate SodiumINACTIVE INGREDIENTMP1J8420LU2
iodopropynyl butylcarbamateINACTIVE INGREDIENT603P14DHEB2
menthyl lactateINACTIVE INGREDIENT2BF9E65L7I2
propylene glycolINACTIVE INGREDIENT6DC9Q167V32
sodium stearateINACTIVE INGREDIENTQU7E2XA9TG2
steareth-21INACTIVE INGREDIENT53J3F32P582
trolamineINACTIVE INGREDIENT9O3K93S3TK2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51068-50351068-503-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 182 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
Edetate SodiumEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
Edetate SodiumEDETATE SODIUMMP1J8420LUEMULSION / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
steareth-21STEARETH-2153J3F32P58LOTION / TOPICAL3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
sodium stearateSODIUM STEARATEQU7E2XA9TGTABLET, ORALLY DISINTEGRATING / ORAL0.85 mgExact identifier — unii candidate
3 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
alcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
sodium stearateSODIUM STEARATEQU7E2XA9TGTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
Edetate SodiumEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii candidate
12 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2ab5e94f-2b75-48bc-98d5-81e71f64227bcdf0a374-2a2c-4e79-94f5-23746084d5e12011-06-09WarningsExact identifier
spl id: 2ab5e94f-2b75-48bc-98d5-81e71f64227b
spl set id: cdf0a374-2a2c-4e79-94f5-23746084d5e1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.