mind-body matrix pain relief cream

mind-body matrix pain relief cream
SPL v4
SPL
SPL Set ID 3667dd0d-942e-4101-ba98-cb013ae77cf5
Route
topical
Published
Effective Date 2018-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (15 mg)
Inactive Ingredients
aloe vera leaf water arnica montana flower indian frankincense calendula officinalis flower cetearyl olivate cetyl alcohol chamomile gluconolactone glycerin glyceryl stearate citrate helianthus annuus flowering top lavender oil melaleuca alternifolia leaf peppermint oil methyl salicylate dimethyl sulfone silicon dioxide sodium benzoate sorbitan olivate starch, tapioca theanine xanthan gum corn

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-04-20 Until 2021-10-30

Description

MENTHOL 1.50%


Medication Information

Description

MENTHOL 1.50%

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.
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.

Do Not Apply 
  • TO WOUNDS OR DAMAGED SKIN.
  • DO NOT BANDAGE TIGHTLY.
Package Labeling:

Active Ingredient:

MENTHOL 1.50%

Other Ingredients:

ALOE BARBADENSIS (ALOE VERA GEL) JUICE, AQUA (DEIONIZED WATER), ARNICA MONTANA FLOWER EXTRACT, BOSWELLIA SERRATA EXTRACT, CALENDULA 0FFICINALIS EXTRACT, CETEARYL OLIVATE, CETYL ALCOHOL, CHAMOMILLA RECUTITA (CHAMOMILE) EXTRACT, CITRUS LIMONUM MEDICA (LEMON BALM) EXTRACT, G-AMINOBUTYRIC ACID, GLUCONOLACTONE, GLYCERIN, GLYCERYL STEARATE, HELIANTHUS

ANNUUS (SUNFLOWER) OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, LECITHIN, MELALEUCA ALTERNIFOLIA (TEA TREE) OIL, MENTHA

PIPERITA (PEPPERMINT) OIL, METHYL SALICYLATE (WINTERGREEN) OIL, METHYLSULFONYLMETHANE (MSM), SILICA, SODIUM BENZOATE, SORBITAN OLIVATE, TAPIOCA STARCH, L-THEANINE, XANTHAN GUM, ZEMEA (CORN) PROPANEDIOL.

Additional Information:

STORE AT ROOM TEMPERATURE.

Keep Out of Reach of Children.

IF SWALLOWED, CONSULT PHYSICIAN

If Pregnant Or Breast Feeding, 

CONTACT PHYSICIAN PRIOR TO USE.


Structured Label Content

Section 55105-1 (55105-1)

TOPICAL ANALGESIC

Warnings: (WARNINGS:)
  • FOR EXTERNAL USE ONLY.
  • AVOID CONTACT WITH EYES.
  • IF SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS, DISCONTINUE USE AND CONSULT PHYSICIAN.
Directions: (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: (INDICATIONS:)

FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF THE MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, SPRAINS, BRUISES AND STRAINS.

Do Not Apply  (DO NOT APPLY )
  • TO WOUNDS OR DAMAGED SKIN.
  • DO NOT BANDAGE TIGHTLY.
Package Labeling:

Active Ingredient: (ACTIVE INGREDIENT:)

MENTHOL 1.50%

Other Ingredients: (OTHER INGREDIENTS:)

ALOE BARBADENSIS (ALOE VERA GEL) JUICE, AQUA (DEIONIZED WATER), ARNICA MONTANA FLOWER EXTRACT, BOSWELLIA SERRATA EXTRACT, CALENDULA 0FFICINALIS EXTRACT, CETEARYL OLIVATE, CETYL ALCOHOL, CHAMOMILLA RECUTITA (CHAMOMILE) EXTRACT, CITRUS LIMONUM MEDICA (LEMON BALM) EXTRACT, G-AMINOBUTYRIC ACID, GLUCONOLACTONE, GLYCERIN, GLYCERYL STEARATE, HELIANTHUS

ANNUUS (SUNFLOWER) OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, LECITHIN, MELALEUCA ALTERNIFOLIA (TEA TREE) OIL, MENTHA

PIPERITA (PEPPERMINT) OIL, METHYL SALICYLATE (WINTERGREEN) OIL, METHYLSULFONYLMETHANE (MSM), SILICA, SODIUM BENZOATE, SORBITAN OLIVATE, TAPIOCA STARCH, L-THEANINE, XANTHAN GUM, ZEMEA (CORN) PROPANEDIOL.

Additional Information: (ADDITIONAL INFORMATION:)

STORE AT ROOM TEMPERATURE.

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

IF SWALLOWED, CONSULT PHYSICIAN

If Pregnant Or Breast Feeding,  (IF PREGNANT OR BREAST FEEDING, )

CONTACT PHYSICIAN PRIOR TO USE.


Advanced Ingredient Data


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