Real Time Pain Relief Cream

Real Time Pain Relief Cream
SPL v1
SPL
SPL Set ID 617d4c4c-c540-f7a3-e053-2991aa0afc0e
Route
TOPICAL
Published
Effective Date 2017-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.25 g)
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Flower Capsicum Frutescens Whole Anthemis Arvensis Flowering Top Butylene Glycol Carbomer 940 Coriandrum Sativum Whole Water Calendula Officinalis Seed Oil Centaurea Cyanus Flower Sodium Chondroitin Sulfate (porcine; 5500 Mw) Hypericum Perforatum Phenoxyethanol Emu Oil Cetostearyl Alcohol Diazolidinyl Urea Glucosamine Hydrochloride Hamamelis Virginiana Bark Salix Alba Bark Tert-butyl Alcohol Matricaria Chamomilla Flowering Top Oil 3,4-methylenedioxybenzyl Methylsulfone Cetyl Alcohol Caprylyl Glycol Sorbitol Tilia Cordata Flower Triethanolamine Tris(dihydrogen Phosphate)

Identifiers & Packaging

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

Description

Menthol 1.25%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 1.25%

Uses

temporarily relieves minor pain associated with:

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

for external use only

Directions:

​adults and children over 2 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

children 2 years or younger: ask a doctor

Active Ingredient

Menthol 1.25%

Inactive Ingredients:

Aloe Barbadensis Leaf, Anthemis nobilis Extract, Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis Extract, Caprylyl Glycol, Capsicum Frutescens Fruit, Carbomer, Centaurea cyanus Extract, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Diazolidinyl Urea, Emu Oil, Fragrance, Glucosamine HCI, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum Extract, Matricaria chamomilla Extract, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sodium Chondroitin Sulfate, Sorbitol, Tilia cordata Extract, Triethanolamine.

When Using This Product
  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
Stop Use 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
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use

Package Label, Principal Display Panel and Drug Facts


Structured Label Content

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps
Purpose

Topical Analgesic

Warnings

for external use only

Directions:

​adults and children over 2 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

children 2 years or younger: ask a doctor

Active Ingredient

Menthol 1.25%

Inactive Ingredients: (Inactive ingredients:)

Aloe Barbadensis Leaf, Anthemis nobilis Extract, Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis Extract, Caprylyl Glycol, Capsicum Frutescens Fruit, Carbomer, Centaurea cyanus Extract, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Diazolidinyl Urea, Emu Oil, Fragrance, Glucosamine HCI, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum Extract, Matricaria chamomilla Extract, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sodium Chondroitin Sulfate, Sorbitol, Tilia cordata Extract, Triethanolamine.

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use 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
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.

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

ask a health professional before use

Package Label, Principal Display Panel and Drug Facts


Advanced Ingredient Data


Raw Label Data

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