Alo Therapeutic Massage

Dosage form: cream
Ingredients: MENTHOL 3g in 100g, HISTAMINE DIHYDROCHLORIDE 0.1g in 100g
Labeler: Theraplex Solutions
NDC Code: 51457-000

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Alo Therapeutic Massage

Drug Facts


Active Ingredients

Menthol                                   3.00%

Histamine Dihydrochloride    0.100%  

Purpose

External Analgesic

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

Warnings
  • 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.

If swallowed, consult physician.  Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

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

Other Ingredients

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:

THERAPLEX SOLUTIONS

Miami, Florida 33298  

Questions?  call 305.609.4229

www.alo-21.com

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)

ALO THERAPEUTIC MASSAGE 
menthol, histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51457-000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3 g  in 100 g
HISTAMINE DIHYDROCHLORIDE (HISTAMINE) HISTAMINE DIHYDROCHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
CETYL ALCOHOL 
ETHYLHEXYLGLYCERIN 
SUNFLOWER OIL 
SPEARMINT OIL 
MINERAL OIL 
PEG-100 STEARATE 
PHENOXYETHANOL 
TROLAMINE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:51457-000-04118 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34806/07/2012
Labeler - Theraplex Solutions (078500057)
Establishment
NameAddressID/FEIOperations
Pure Source Inc.969241041manufacture

Revised: 06/2012
 
Theraplex Solutions

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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