pure personal all natural pain relief cream

pure personal all natural pain relief cream
SPL v2
SPL
SPL Set ID 8f3fb1d0-d238-4b4c-9816-7e335258d71d
Route
topical
Published
Effective Date 2022-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (75 mg)
Inactive Ingredients
water yellow wax frankincense oil cannabis sativa seed oil caprylyl glycol cetostearyl alcohol cetearyl glucoside citric acid monohydrate orange oil, cold pressed eucalyptus oil clove oil glyceryl laurate glyceryl monostearate helianthus annuus flowering top isopropyl alcohol mango peppermint oil methyl salicylate tocopherol xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-10-24

Purpose

Topical Analgesic

Description

Menthol 7.5 %


Medication Information

Purpose

Topical Analgesic

Description

Menthol 7.5 %

Uses:

• For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains. 

Warnings:

For external use only.

Do Not Use

• on damaged or broken skin.

Directions:

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: consult a doctor.

Package Labeling:

Active Ingredients

Menthol 7.5 %

Other Information:

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Aqua (Deionized Water), Beeswax, Boswellia Carterii (Frankincense) Oil, Camphor, Cannabis Sativa (Hemp) Seed Oil, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, Eucalyptus Globulus Oil, Eugenia Caryophyllus (Clove) Bud Oil, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Isopropyl Alcohol, Mangifera Indica (Mango) Butter, Mentha Piperita (Peppermint) Oil, Methyl Salicylate, Tocopherol (Vitamin E), Xanthan Gum.

Questions Or Comments?

419-461-9916

When Using This Product 

• Avoid contact with the eyes • Do not bandage tightly.

Stop Use and Ask A Doctor If

• rash or irritation develops and lasts • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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.


Structured Label Content

Purpose

Topical Analgesic

Uses:

• For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains. 

Warnings:

For external use only.

Do Not Use (Do not use)

• on damaged or broken skin.

Directions:

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: consult a doctor.

Package Labeling:

Active Ingredients

Menthol 7.5 %

Other Information: (Other information:)

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients: (Inactive ingredients:)

Aqua (Deionized Water), Beeswax, Boswellia Carterii (Frankincense) Oil, Camphor, Cannabis Sativa (Hemp) Seed Oil, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, Eucalyptus Globulus Oil, Eugenia Caryophyllus (Clove) Bud Oil, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Isopropyl Alcohol, Mangifera Indica (Mango) Butter, Mentha Piperita (Peppermint) Oil, Methyl Salicylate, Tocopherol (Vitamin E), Xanthan Gum.

Questions Or Comments? (Questions or comments?)

419-461-9916

When Using This Product  (When using this product )

• Avoid contact with the eyes • Do not bandage tightly.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash or irritation develops and lasts • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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.


Advanced Ingredient Data


Raw Label Data

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