FDA.reportPublic FDA data

ULTRACIN M

Manufacturer
Cal Pharma
Effective date
2019-11-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:57:35

Label at a glance#

ProductULTRACIN M
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

Temporarily relieves mild aches, pains, and in.ammation of muscle and joints associated with nerve damage and sport injuries.

Dosage and administration

Adults and children over 12 years: Apply to a.ected area and gently massage over area until absorbed. Do not use more than 4 timesa day. Wash hands after gel is applied.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

MENTHOL (10%)

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

USES

INDICATIONS & USAGE SECTION

Temporarily relieves mild aches, pains, and in.ammation of muscle and joints associated with nerve damage and sport injuries.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

WARNINGS

WARNINGS SECTION

For external use only. Do not use on open wounds, cuts, damaged or infected skin as well as in the eye, mouth, genitals or any other mucous membrane. Stop use and consult your physican if pain is persistent or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years: Apply to a.ected area and gently massage over area until absorbed. Do not use more than 4 timesa day. Wash hands after gel is applied.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Arnica Montana (Arnica) Flower Extract, Benzyl Alcohol, Boswelia Serrata Extract, Citrus Limon,Denatured Dehydrated Alcohol 40B, Gaultheria Procumbens (Wintergreen) Leaf Oil Extract, Petasites Japonicus Root (Butterbur) Extract,Pine (Pinetree) Bark Extract, Salix Nigra (Willow) Bark Extract, Zanthoxylum Americanum (Prickly Ash) Bark Extract, Zanthoxylum Bungeanum Fruit (Sichuan Peppercorn) Extract, Water

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

1-888-551-7778

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultracin M copyUltracin M copy

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55628-9051-42024-04-01C16284748780-1d6a99b39-9f3d-a426-e053-dadaa90af4c24ff54f99-5eec-4209-932e-3ad076309c52
55628-9051-42022-01-28C16284748780-1d6a99b39-9f3d-a426-e053-dadaa90af4c24ff54f99-5eec-4209-932e-3ad076309c52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55628-9051-4ML - Milliliter55628-9051c6ab4dbc-e291-4331-8d54-90396aeb904912015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
MENTHOLACTIVE MOIETYL7T10EIP3A1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q1
ARNICA MONTANA FLOWER WATERINACTIVE INGREDIENTU7L2JP51PR1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
BOSWELLIA SERRATA WHOLEINACTIVE INGREDIENTX7B7P649WQ1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995L1
GAULTHERIA PROCUMBENS LEAFINACTIVE INGREDIENT2125M16OWN1
LIME (CITRUS)INACTIVE INGREDIENT8CZS5469541
MARITIME PINEINACTIVE INGREDIENT50JZ5Z98QY1
PETASITES JAPONICUS ROOTINACTIVE INGREDIENT6F650HF10T1
SALIX NIGRA BARKINACTIVE INGREDIENTQU52J3A5B31
WATERINACTIVE INGREDIENT059QF0KO0R1
ZANTHOXYLUM AMERICANUM BARKINACTIVE INGREDIENTA4KL1HMZ7T1
ZANTHOXYLUM BUNGEANUM FRUITINACTIVE INGREDIENT3CIP16A4181

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55628-905155628-9051-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
ARNICA MONTANA FLOWER WATERU7L2JP51PRIACT
BENZYL ALCOHOLLKG8494WBHIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
LIME (CITRUS)8CZS546954IACT
ALCOHOL3K9958V90MIACT
GAULTHERIA PROCUMBENS LEAF2125M16OWNIACT
PETASITES JAPONICUS ROOT6F650HF10TIACT
MARITIME PINE50JZ5Z98QYIACT
SALIX NIGRA BARKQU52J3A5B3IACT
ZANTHOXYLUM AMERICANUM BARKA4KL1HMZ7TIACT
ZANTHOXYLUM BUNGEANUM FRUIT3CIP16A418IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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 2 · 113 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / SUBCUTANEOUS225 mgExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / SOFT TISSUE40 mgExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRAMUSCULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCONJUNCTIVAL252 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRA-ARTICULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY, METERED / NASAL5 mg/1mlExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAMUSCULAR54 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAVENOUS1620 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRALESIONAL20 mgExact identifier — unii candidate
50 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY / NASAL5 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / RECTAL124 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR144 mgExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAMUSCULAR225 mgExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 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
150ddb0a-1da0-4270-e063-6394a90afba44ff54f99-5eec-4209-932e-3ad076309c522024-04-01WarningsExact identifier
spl set id: 4ff54f99-5eec-4209-932e-3ad076309c52

Reported adverse events (FAERS/openFDA)#

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