Frankincense & Myrrh Intensive Foot Therapy Lotion

Frankincense & Myrrh Intensive Foot Therapy Lotion
SPL v2
SPL
SPL Set ID 23e56c6b-0f2b-721f-e063-6394a90a1ed0
Route
TOPICAL
Published
Effective Date 2024-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.3 g)
Inactive Ingredients
Water Medium-chain Triglycerides Geranium Oil, Algerian Type Nutmeg Oil Stearyl Alcohol Polysorbate 60 Eucalyptus Oil Phenoxyethanol Myrrh Oil Lanolin Cetostearyl Alcohol Glycerin Cocoa Butter Glyceryl Monostearate Coconut Oil Bergamot Oil Cetyl Alcohol Rosemary Oil Xanthan Gum Cinnamon Oil Frankincense Oil Lemon Oil, Cold Pressed Shea Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-09

Description

Menthol 1.3%

Purpose

Menthol 1.3%................Topical Analgesic


Medication Information

Purpose

Menthol 1.3%................Topical Analgesic

Description

Menthol 1.3%

Uses

For the temporary relief of minor aches and pains.

Section 50565-1

Keep out of the 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
  • irritation occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7

When using this product

  • avoid contact with the eyes
  • do not bandage tightly
Section 50570-1

Do not use

  • on wounds or damaged skin
  • over large areas of the body
Section 51945-4

Frankincense & Myrrh

Intensive

Foot

Therapy

Lotion

Safe for Diabetics

Fast

Pain Relief

Hydrating Repair

Menthol 1.3%

Temporary

Topical Analgesic

Net Wt. 3 oz (85g)

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Warnings

For external use only

Directions

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: consult a doctor.

Active Ingredient

Menthol 1.3%

Other Information
  • store in a cool, dry place
  • tamper resistant: do not use if seal under tube cap is broken or missing
Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Lanolin, Cetearyl Alcohol, Glycerin, Theobroma Cacao (Cocoa) Seed Butter, Cetyl Alcohol, Stearyl Alcohol, Glyceryl Stearyl, Rosmarinus Officinalis (Rosemary) Leaf Oil, Polysorbate 60, Eucalyptus Globulus Leaf Oil, Pelargonium Graveolens (Geranium) Oil, Phenoxyethanol, Xanthan Gum, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Boswellia Carterii (Frankincense) Oil, Commiphora Myrrha (Myrrh) Oil, Citrus Medica Limonum (Lemon) Peel Oil

Questions Or Comments?

1-877-917-9674 Mon-Fri, 9 a.m. - 5 p.m. EST

www.frankincensemyrrh.com


Structured Label Content

Uses

For the temporary relief of minor aches and pains.

Section 50565-1 (50565-1)

Keep out of the 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
  • irritation occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • avoid contact with the eyes
  • do not bandage tightly
Section 50570-1 (50570-1)

Do not use

  • on wounds or damaged skin
  • over large areas of the body
Section 51945-4 (51945-4)

Frankincense & Myrrh

Intensive

Foot

Therapy

Lotion

Safe for Diabetics

Fast

Pain Relief

Hydrating Repair

Menthol 1.3%

Temporary

Topical Analgesic

Net Wt. 3 oz (85g)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

Menthol 1.3%................Topical Analgesic

Warnings

For external use only

Directions

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: consult a doctor.

Active Ingredient (Active ingredient)

Menthol 1.3%

Other Information (Other information)
  • store in a cool, dry place
  • tamper resistant: do not use if seal under tube cap is broken or missing
Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Lanolin, Cetearyl Alcohol, Glycerin, Theobroma Cacao (Cocoa) Seed Butter, Cetyl Alcohol, Stearyl Alcohol, Glyceryl Stearyl, Rosmarinus Officinalis (Rosemary) Leaf Oil, Polysorbate 60, Eucalyptus Globulus Leaf Oil, Pelargonium Graveolens (Geranium) Oil, Phenoxyethanol, Xanthan Gum, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Boswellia Carterii (Frankincense) Oil, Commiphora Myrrha (Myrrh) Oil, Citrus Medica Limonum (Lemon) Peel Oil

Questions Or Comments? (Questions or comments?)

1-877-917-9674 Mon-Fri, 9 a.m. - 5 p.m. EST

www.frankincensemyrrh.com


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