ALO THERAPEUTIC MASSAGE- menthol, histamine dihydrochloride cream

Alo Therapeutic Massage by

Drug Labeling and Warnings

Alo Therapeutic Massage by is a Otc medication manufactured, distributed, or labeled by Theraplex Solutions, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Menthol                                   3.00%

Histamine Dihydrochloride    0.100%  

Purpose

External Analgesic

Uses

For 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

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)

INGREDIENTS AND APPEARANCE

ALO THERAPEUTIC MASSAGE 
menthol, histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51457-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g  in 100 g
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SPEARMINT OIL (UNII: C3M81465G5)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51457-000-04	118 g in 1 TUBE; Type 0: Not a Combination Product	02/03/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/07/2012

Labeler - Theraplex Solutions (078500057)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(51457-000)