rubbing dots pain relieving cream

rubbing dots pain relieving cream
SPL v5
SPL
SPL Set ID 137a88ff-e409-4a67-addc-883194c356ae
Route
topical
Published
Effective Date 2020-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (50 mg)
Inactive Ingredients
aloe vera leaf water arnica montana whole indian frankincense shea butter calendula officinalis flower cetostearyl alcohol ethylhexylglycerin glycerin glyceryl monostearate c13-14 isoparaffin isopropyl alcohol isostearyl palmitate laureth-7 dimethyl sulfone peg-100 stearate phenoxyethanol propylene glycol stearic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-05-21

Description

Menthol 5.00%


Medication Information

Description

Menthol 5.00%

Section 50570-1

Do not apply to wounds or damaged skin.

Do not bandage tightly.

Section 53414-9

If pregnant or breast feeding, contact physician prior to use.

Section 55105-1

Topical Analgesic

Warnings:

For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician.

Drug Facts:

Directions:

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.

Children under two-years of age: consult a physician.

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Active Ingredient:

Menthol 5.00%

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, *Butyrospermum Parkii (Shea) Butter, *Calendula Officinalis Extract, Cetearyl Alcohol, Ethylhexylglycerin, *Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Alcohol, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid.

Additional Information:

Store at room temperature.

Keep Out of Reach of Children.

If swallowed, consult physician.

Package Labeling: 73294 005 04

Package Labeling: 73294 005 28


Structured Label Content

Section 50570-1 (50570-1)

Do not apply to wounds or damaged skin.

Do not bandage tightly.

Section 53414-9 (53414-9)

If pregnant or breast feeding, contact physician prior to use.

Section 55105-1 (55105-1)

Topical Analgesic

Warnings:

For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician.

Drug Facts: (DRUG FACTS:)

Directions:

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.

Children under two-years of age: consult a physician.

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Active Ingredient:

Menthol 5.00%

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, *Butyrospermum Parkii (Shea) Butter, *Calendula Officinalis Extract, Cetearyl Alcohol, Ethylhexylglycerin, *Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Alcohol, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid.

Additional Information:

Store at room temperature.

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

If swallowed, consult physician.

Package Labeling: 73294 005 04 (Package Labeling: 73294-005-04)

Package Labeling: 73294 005 28 (Package Labeling: 73294-005-28)


Advanced Ingredient Data


Raw Label Data

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