Drug Facts

Active ingredients

Menthol 3.00%

Histamine Dihydrochloride 0.100%

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.

Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions

Apply directly to affected 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.

Package Labeling:

Label4

ALO THERAPEUTIC MASSAGE
menthol, histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71061-766
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SPEARMINT OIL (UNII: C3M81465G5)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71061-766-05	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/10/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/10/2016

Labeler - CMI Therapy Solutions (080327444)

Alo Therapeutic Massage Cream