Real Time Pain Relief Foot Cream

Real Time Pain Relief Foot Cream
SPL v1
SPL
SPL Set ID 61e41c3f-b760-4b3d-e053-2991aa0a3248
Route
TOPICAL
Published
Effective Date 2013-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.5 g)
Inactive Ingredients
Tilia X Europaea Flower Alpha-tocopheryloxyacetic Acid Ascorbic Acid Butylene Glycol Matricaria Chamomilla Flowering Top Oil Polysorbate 60 Aloe Vera Leaf Allantoin Chamomile Flower Oil Lactic Acid Calendula Officinalis Flower Lanolin Melaleuca Alternifolia Leaf Centaurea Cyanus Flower Cetyl Alcohol Coriander Oil Polysorbate 20 Emu Oil Water Salix Alba Bark Paraffin Petrolatum Caprylyl Glycol Eucalyptus Globulus Leaf Hydrogenated Cottonseed Oil Hypericum Perforatum Phenoxyethanol Retinyl Propionate .alpha.-isobutylphenethyl Alcohol Sodium Borate Sorbitan Sesquioleate Isostearyl Alcohol

Identifiers & Packaging

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

Description

Menthol 1.5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 1.5%

Uses

Temporarily relieves minor pain associated with

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

for external use only

Directions

Active Ingredient

Menthol 1.5%

Inactive Ingredients

Allantoin, Aloe barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Ascorbic Acid, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Eucalyptus globulus Leaf Oil, Hydrogenated Vegetable Oil, Hypericum perforatum (St. John’s Wort), Lactic Acid, Lanolin, Matricaria chamomilla (Chamomile), Melaleuca alternifolia (Tea Tree) Leaf Oil, Paraffin, Petrolatum, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Purified Water, Retinyl Palmitate, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sodium Borate, Sorbitan Sesquioleate, Stearyl Alcohol, Tilia sylvestris (Lime Tree), Tocopheryl Acetate.

When Using This Product
  • use only as directed
  • do not bandage tightly or use with heating pad
  • avoid contact with eyes or mucus membranes
  • do not apply to wounds or damaged skin
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

Principal Display Panel and Drug Facts


Structured Label Content

Uses (USES)

Temporarily relieves minor pain associated with

  • arthritis
  • muscle strains
  • sprains
  • bruises
  • cramps
Purpose (PURPOSE)

Topical analgesic

Warnings (WARNINGS)

for external use only

Directions (DIRECTIONS)

Active Ingredient (ACTIVE INGREDIENT)

Menthol 1.5%

Inactive Ingredients (INACTIVE INGREDIENTS)

Allantoin, Aloe barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Ascorbic Acid, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Eucalyptus globulus Leaf Oil, Hydrogenated Vegetable Oil, Hypericum perforatum (St. John’s Wort), Lactic Acid, Lanolin, Matricaria chamomilla (Chamomile), Melaleuca alternifolia (Tea Tree) Leaf Oil, Paraffin, Petrolatum, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Purified Water, Retinyl Palmitate, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sodium Borate, Sorbitan Sesquioleate, Stearyl Alcohol, Tilia sylvestris (Lime Tree), Tocopheryl Acetate.

When Using This Product (When using this product)
  • use only as directed
  • do not bandage tightly or use with heating pad
  • avoid contact with eyes or mucus membranes
  • do not apply to wounds or damaged skin
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

Principal Display Panel and Drug Facts (PRINCIPAL DISPLAY PANEL and DRUG FACTS)


Advanced Ingredient Data


Raw Label Data

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