FDA.reportPublic FDA data

Alo Therapeutic Massage

Manufacturer
Theraplex Solutions | Pure Source, LLC
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:54

Label at a glance#

ProductAlo Therapeutic Massage
Active ingredientMENTHOL, HISTAMINE DIHYDROCHLORIDE
Label structure11 sections

Indications and uses

For temporary relief of minor aches and pains associated with backache, arthritis, bruises and sprains.

Dosage and administration

Apply directly to effected area. Do not use more than four times per day.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol                                   3.00%

Histamine Dihydrochloride    0.100%  

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains associated with backache, arthritis, bruises and sprains.

Warnings

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes.
  • Do not apply to open wounds or damages skin.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.  Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician prior to use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply directly to effected area.
  • Do not use more than four times per day.

Other Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Butylene Glycol, Carbomer, Cetyl Alcohol, Ethylhexylglycerin, Dimethyl Sulfone(MSM), Glyceryl Stearate, Healianthus Annuus (Sunflower) Oil, Mentha Viridis (Spearmint) Oil, Mineral Oil, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, SD-Alcohol 40B, Triethanolamine, Xanthan Gum.

Distributed by:

SPL UNCLASSIFIED SECTION

THERAPLEX SOLUTIONS

Miami, Florida 33298  

Questions?  call 305.609.4229

www.alo-21.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alo THERAPEUTIC MASSAGE CREAM; PAIN RELIEVING; DEEP PENETRATING, PAIN RELIEF FROM ARTHRITIS; SORE MUSCLES AND JOINTS; BACK PAIN;BRUISES AND SPRAINS STIMULATES CIRCULATION TO SPEED HEALING 4 fl oz Drug Facts

Alo Therapeutic Massage Cream 4oz/118g (51457-000-04)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alo 1Alo 1Alo 2Alo 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1300293Alo (histamine dihydrochloride 0.1 % / menthol 3 % ) Topical CreamPSN4
1300288histamine dihydrochloride 0.1 % / menthol 3 % Topical CreamPSN4
1300293histamine dihydrochloride 1 MG/ML / menthol 30 MG/ML Topical Cream [Alo]SBD4
1300288histamine dihydrochloride 1 MG/ML / menthol 30 MG/ML Topical CreamSCD4
1300293Alo (histamine dihydrochloride 0.1 % / menthol 3 % ) Topical CreamSY4
1300288histamine dihydrochloride 0.1 % / menthol 3 % Topical CreamSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51457-000-04Alo Therapeutic Massage118 g in 1 TUBECREAM1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51457-000ALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20231111_a898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HISTAMINE DIHYDROCHLORIDEACTIVE INGREDIENT3POA0Q644U1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
HISTAMINEACTIVE MOIETY820484N8I31
MENTHOLACTIVE MOIETYL7T10EIP3A1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
SPEARMINT OILINACTIVE INGREDIENTC3M81465G51
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51457-00051457-000-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
MENTHOLL7T10EIP3AACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SUNFLOWER OIL3W1JG795YIIACT
SPEARMINT OILC3M81465G5IACT
MINERAL OILT5L8T28FGPIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TROLAMINE9O3K93S3TKIACT

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 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SPEARMINT OILSPEARMINT OILC3M81465G5OINTMENT / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SPEARMINT OILSPEARMINT OILC3M81465G5OINTMENT / TOPICALNAExact identifier — unii+route
2 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
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDETheraplex Solutionsa898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d42023-11-10WarningsExact identifier
ndc (package): 51457-000-04
ndc (product): 51457-000
ndc11 (package): 51457000004
spl id: 09d7052e-ec73-ef60-e063-6294a90af214
spl set id: a898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d4

Reported adverse events (FAERS/openFDA)#

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