FDA.reportPublic FDA data

Alo Therapeutic Massage Cream

Manufacturer
CMI Therapy Solutions
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:50

Label at a glance#

ProductAlo Therapeutic Massage
Active ingredientMENTHOL, HISTAMINE DIHYDROCHLORIDE
Label structure6 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 affected 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%

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

OTC - DO NOT USE SECTION

  • to open wounds or damaged 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 affected 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, Helianthus Annuus (Sunflower) Oil, Mentha Viridis (Spearmint) Oil, Mineral Oil, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, SD-Alcohol 40B, Triethanolamine, Xanthan Gum.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1300293Alo (histamine dihydrochloride 0.1 % / menthol 3 % ) Topical CreamPSN2
1300288histamine dihydrochloride 0.1 % / menthol 3 % Topical CreamPSN2
1300293histamine dihydrochloride 1 MG/ML / menthol 30 MG/ML Topical Cream [Alo]SBD2
1300288histamine dihydrochloride 1 MG/ML / menthol 30 MG/ML Topical CreamSCD2
1300293Alo (histamine dihydrochloride 0.1 % / menthol 3 % ) Topical CreamSY2
1300288histamine dihydrochloride 0.1 % / menthol 3 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71061-765-28Alo Therapeutic Massage3785 mL in 1 BOTTLECREAM37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71061-765ALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [CMI THERAPY SOLUTIONS]2Current NDC, Legacy NDC, 1 package rows20231111_40f93076-1f68-58e6-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71061-76571061-765-28

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
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SUNFLOWER OIL3W1JG795YIIACT
SPEARMINT OILC3M81465G5IACT
MINERAL OILT5L8T28FGPIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TROLAMINE9O3K93S3TKIACT
XANTHAN GUMTTV12P4NEEIACT
MENTHOLL7T10EIP3AACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB

Source Document#

Source XML

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 DIHYDROCHLORIDECMI Therapy Solutions40f93076-1f68-58e6-e054-00144ff88e882023-11-10WarningsExact identifier
ndc (package): 71061-765-28
ndc (product): 71061-765
ndc11 (package): 71061076528
spl id: 09d769cf-cc55-9fd3-e063-6394a90ac18e
spl set id: 40f93076-1f68-58e6-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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