Real Time Pain Relief Sports Cream

Real Time Pain Relief Sports Cream
SPL v1
SPL
SPL Set ID 61d18e02-8b44-7c40-e053-2991aa0afbd2
Route
TOPICAL
Published
Effective Date 2013-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.5 g)
Inactive Ingredients
Aloe Vera Leaf Chamaemelum Nobile Flower Arnica Montana Flower Calendula Officinalis Flower Carbomer 934 Centaurea Cyanus Flower Cetostearyl Alcohol Cetyl Alcohol Coriander Oil Magnesium Chloride Emu Oil Glucosamine Hydrochloride Hamamelis Virginiana Top Water Salix Alba Bark Sorbitol Tilia X Europaea Flower Myristica Fragrans Whole Tetrasodium Diethylenetriaminepentamethylenephosphonate Butylene Glycol Caprylyl Glycol Curcuma Longa Leaf Dimethyl Sulfone 2-(dipropylamino)ethanol Helichrysum Italicum Flower Jasminum Officinale Flower Lavender Oil Origanum Majorana Phenoxyethanol Rosmarinus Officinalis Flowering Top Oil Triethanolamine Tris(dihydrogen Phosphate) Hypericum Perforatum Anthemis Arvensis Flowering Top Cupressus Sempervirens Leaf Oil Gaultheria Procumbens Leaf Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-01-30

Description

Menthol 0.5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 0.5%

Uses

Temporarily relieves minor pain associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
Warnings

for external use only

Directions

Active Ingredient

Menthol 0.5%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria Chamomilla), Coriandrum Sativum (Coriander) Fruit Oil, Curcuma Longa (Turmeric) Extract, Cupressus sempervirens (Cypress) Fruit Extract, Emu Oil, Fragrance, Gaultheria procumbens (Wintergreen) Oil, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Helichrysum Italicum Flower, Hypericum perforatum (St. John’s Wort), Jasminum Officianale (Jasmine) Flower Extract, Lavendula Angustifolia (Lavender) Oil, Magnesium Chloride, Methylsulfonylmethane, Myristica Fragrans (Nutmeg) Extract, Origanum Majorana (Marjoram) Leaf Extract, Phenoxyethanol, Purified Water, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.

Principal Display Panel

When Using This Product
  • use only as directed
  • avoid contact with eyes or mucus membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
Children 12 Years Or Younger

ask a doctor

If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center right away.

Stop Using and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops
Adults and Children Over 2 Years
  • apply generously to affected area
  • massage into painful area until throughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

children 2 years or younger: ask a doctor


Structured Label Content

Uses (USES)

Temporarily relieves minor pain associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
Purpose (PURPOSE)

Topical analgesic

Warnings (WARNINGS)

for external use only

Directions (DIRECTIONS)

Active Ingredient (ACTIVE INGREDIENT)

Menthol 0.5%

Inactive Ingredients (INACTIVE INGREDIENTS)

Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria Chamomilla), Coriandrum Sativum (Coriander) Fruit Oil, Curcuma Longa (Turmeric) Extract, Cupressus sempervirens (Cypress) Fruit Extract, Emu Oil, Fragrance, Gaultheria procumbens (Wintergreen) Oil, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Helichrysum Italicum Flower, Hypericum perforatum (St. John’s Wort), Jasminum Officianale (Jasmine) Flower Extract, Lavendula Angustifolia (Lavender) Oil, Magnesium Chloride, Methylsulfonylmethane, Myristica Fragrans (Nutmeg) Extract, Origanum Majorana (Marjoram) Leaf Extract, Phenoxyethanol, Purified Water, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with eyes or mucus membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
Children 12 Years Or Younger (children 12 years or younger)

ask a doctor

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

ask a health professional before use

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

If swallowed, get medical help or contact a poison control center right away.

Stop Using and Ask A Doctor If (Stop using and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops
Adults and Children Over 2 Years (adults and children over 2 years)
  • apply generously to affected area
  • massage into painful area until throughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

children 2 years or younger: ask a doctor


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)