ALO THERAPEUTIC MASSAGE PAIN RELIEVING- menthol, histamine dihydrochloride cream

ALO THERAPEUTIC MASSAGE PAIN RELIEVING by

Drug Labeling and Warnings

ALO THERAPEUTIC MASSAGE PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by Theraplex Solutions, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALO THERAPEUTIC MASSAGE CREAM PAIN RELIEVING

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 damaged skin.

If symptoms persist for more than seven days,

discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

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, Helianthus 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
P.O. BOX 770125
MIAMI, FL 33177
Questions? Call 305.609.4229
www.alopainrelief.com

THIS PRODUCT IS NOT TESTED ON ANIMALS.

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 CIRCULATIONS TO SPEED HEALING

32 f l o z

ALO THERAPEUTIC MASSAGE CREAM PAIN RELIEVING 32oz (

51457-001-32)

INGREDIENTS AND APPEARANCE

ALO THERAPEUTIC MASSAGE PAIN RELIEVING 
menthol, histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51457-001
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)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
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: 51457-001-32	1 in 1 PACKAGE	02/22/2017
1		907.18474 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/20/2013

Labeler - Theraplex Solutions (078500057)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(51457-001)