Your browser does not support JavaScript! ALO THERAPEUTIC MASSAGE PAIN RELIEVING (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]
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ALO THERAPEUTIC MASSAGE PAIN RELIEVING (menthol, histamine dihydrochloride) cream
[Theraplex Solutions]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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.

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)

Alo Label

ALO THERAPEUTIC MASSAGE PAIN RELIEVING 
menthol, histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51457-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3.00 g  in 100 g
HISTAMINE DIHYDROCHLORIDE (HISTAMINE) HISTAMINE DIHYDROCHLORIDE0.100 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
CETYL ALCOHOL 
ETHYLHEXYLGLYCERIN 
DIMETHYL SULFONE 
GLYCERYL MONOSTEARATE 
MINERAL OIL 
PEG-100 STEARATE 
PHENOXYETHANOL 
TROLAMINE 
XANTHAN GUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51457-001-321 in 1 PACKAGE
1907.18474 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34803/20/2013
Labeler - Theraplex Solutions (078500057)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source Inc.969241041manufacture(51457-001)

Revised: 3/2013
 
Theraplex Solutions

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