Alo Therapeutic Massage Cream

Alo Therapeutic Massage Cream
SPL v2
SPL
SPL Set ID 40f9622e-27c7-6a5d-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (30 mg) Histamine (1 mg)
Inactive Ingredients
Trolamine Xanthan Gum Water Butylene Glycol Carboxypolymethylene Cetyl Alcohol Ethylhexylglycerin Dimethyl Sulfone Glyceryl Monostearate Sunflower Oil Spearmint Oil Mineral Oil Peg-100 Stearate Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-11-10

Description

Menthol 3.00% Histamine Dihydrochloride 0.100%


Medication Information

Description

Menthol 3.00% Histamine Dihydrochloride 0.100%

Uses

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

Section 55105-1

External Analgesic

Warnings
  • For external use only.
  • Avoid contact with eyes.
Directions
  • Apply directly to affected area.
  • Do not use more than four times per day.
Do Not Apply
  • to open wounds or damaged skin.
  • If symptoms persist for more than seven days, discontinue use and consult physician.
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:

Active Ingredients

Menthol 3.00%

Histamine Dihydrochloride 0.100%

If Pregnant Or Breast Feeding,

contact physician prior to use.

Keep Out of Reach of Children. 

If swallowed, consult physician.

Do not bandage tightly.


Structured Label Content

Uses

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

Section 55105-1 (55105-1)

External Analgesic

Warnings
  • For external use only.
  • Avoid contact with eyes.
Directions
  • Apply directly to affected area.
  • Do not use more than four times per day.
Do Not Apply (Do not apply)
  • to open wounds or damaged skin.
  • If symptoms persist for more than seven days, discontinue use and consult physician.
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:

Active Ingredients (Active ingredients)

Menthol 3.00%

Histamine Dihydrochloride 0.100%

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

contact physician prior to use.

Keep Out of Reach of Children.  (Keep out of reach of children. )

If swallowed, consult physician.

Do not bandage tightly.


Advanced Ingredient Data


Raw Label Data

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