inspiration academy menthol cooling pain relief cream

inspiration academy menthol cooling pain relief cream
SPL v1
SPL
SPL Set ID d04e5e54-6b8a-c7cb-e053-2a95a90aaf6e
Route
topical
Published
Effective Date 2022-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (5.6 g)
Inactive Ingredients
arnica montana flower hippophae rhamnoides seed oil peg-100 stearate hippophae rhamnoides fruit oil shea butter cetostearyl alcohol c13-14 isoparaffin water white wax witch hazel cetearyl glucoside coconut oil laureth-7 lobelia inflata magnesium chloride magnesium gluconate magnesium myristate phenoxyethanol peppermint oil corn oil olive oil xanthan gum magnesium orotate magnesium sulfate, unspecified mangifera indica seed butter polyacrylamide (10000 mw)

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-11-08

Description

Active Ingredients: Menthol 5%


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Active Ingredients:

Menthol 5%

Indications and Usage

Uses:

for temporary relief of minor aches and pains associated with sore muscles, joint discomfort, strains, sprains, bruises and arthritis.

Dosage and Administration

Directions:

adults and children 12 years of age and older

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary
Description

Active Ingredients: Menthol 5%

Section 43683-2

Dosage and Administration

The only change is the effective date

Indications and Usage

The only change is the effective date

Section 50565-1

Keep out of reach of children

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

Section 50566-9

Stop use and ask a doctor if

condition worsens or if symptoms persist for more than seven days or clear up and occur again within a few days

Section 50567-7

When using this product:

  • Do not bandage tightly
  • avoid contact with eye
  • do not apply to wounds or damaged skin
  • do not use heating pads or other heating devices.
Section 51727-6

Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter,

Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water,

Emulsifying Wax, Fragrance, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil,

Laureth-7, Lobelia Inflata (Lobelia) Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Leaf Oil, Olea europaea (Olive) Oil,

Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Xanthan Gum.

Section 51945-4

PACKAGE LABEL AND BOX ART

Section 53413-1

Questions or Comments

PHONE: (941) 795-5466 (LION)

Section 55105-1

Purpose

Topical Analgesic


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Active Ingredients:

Menthol 5%

Indications and Usage (34067-9)

Uses:

for temporary relief of minor aches and pains associated with sore muscles, joint discomfort, strains, sprains, bruises and arthritis.

Dosage and Administration (34068-7)

Directions:

adults and children 12 years of age and older

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary
Section 43683-2 (43683-2)

Dosage and Administration

The only change is the effective date

Indications and Usage

The only change is the effective date

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

condition worsens or if symptoms persist for more than seven days or clear up and occur again within a few days

Section 50567-7 (50567-7)

When using this product:

  • Do not bandage tightly
  • avoid contact with eye
  • do not apply to wounds or damaged skin
  • do not use heating pads or other heating devices.
Section 51727-6 (51727-6)

Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter,

Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water,

Emulsifying Wax, Fragrance, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil,

Laureth-7, Lobelia Inflata (Lobelia) Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Leaf Oil, Olea europaea (Olive) Oil,

Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Xanthan Gum.

Section 51945-4 (51945-4)

PACKAGE LABEL AND BOX ART

Section 53413-1 (53413-1)

Questions or Comments

PHONE: (941) 795-5466 (LION)

Section 55105-1 (55105-1)

Purpose

Topical Analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)