SPL v2
SPL
SPL Set ID 115f1abc-34aa-3c20-e063-6294a90a9764
Route
TOPICAL
Published
Effective Date 2024-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (20 mg)
Inactive Ingredients
Sunflower Oil Eucalyptus Oil Lemon Oil Rosemary Oil Nutmeg Oil Bergamot Oil Cinnamon Leaf Oil Frankincense Oil Geranium Oil, Algerian Type Myrrh Oil Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-14

Description

Menthol 2%

Purpose

Menthol 2% . . . . . . . . . . . . . . . . . Topical Analgesic


Medication Information

Purpose

Menthol 2% . . . . . . . . . . . . . . . . . Topical Analgesic

Description

Menthol 2%

Uses

For temporary relief of minor aches and pains.

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product

 avoid contact with eyes

 do not bandage tightly

Section 50568-5

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 50570-1

Do not use

 on wounds or damaged skin

 over large areas of the body

Section 51945-4

Frankincense & Myrrh

Foot

Pain Relief

Topical Analgesic

Rubbing Oil

Menthol 2%

2 fl oz (59mL)

Section 53414-9

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

Warnings

For external use only

Directions

Adults and children 12 years of age and older: apply 10-30 drops into hand and massage into affected areas

 can be used up to 4 times daily

children under 12 years of age: consult a doctor

Other Information

 store in a cool, dry place

 tamper resistant: do not use if seal around bottle neck is broken or missing

 keep carton, it contains important information

Active Ingredients

Menthol 2%

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Pelargonium Graveolens (Geranium) Leaf Oil, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Citrus Limon (Lemon) Peel Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Boswellia Carterii (Frankincense) Oil, Commiphora Myrrha (Myrrh) Oil,Tocopheryl Acetate.

Questions Or Comments?

1-877-917-9674

M-F, 9am-5pm EST or www.frankincensemyrrh.com


Structured Label Content

Uses

For temporary relief of minor aches and pains.

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 50567-7 (50567-7)

When using this product

 avoid contact with eyes

 do not bandage tightly

Section 50568-5 (50568-5)

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 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

Foot

Pain Relief

Topical Analgesic

Rubbing Oil

Menthol 2%

2 fl oz (59mL)

Section 53414-9 (53414-9)

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

Purpose

Menthol 2% . . . . . . . . . . . . . . . . . Topical Analgesic

Warnings

For external use only

Directions

Adults and children 12 years of age and older: apply 10-30 drops into hand and massage into affected areas

 can be used up to 4 times daily

children under 12 years of age: consult a doctor

Other Information

 store in a cool, dry place

 tamper resistant: do not use if seal around bottle neck is broken or missing

 keep carton, it contains important information

Active Ingredients

Menthol 2%

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Pelargonium Graveolens (Geranium) Leaf Oil, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Citrus Limon (Lemon) Peel Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Boswellia Carterii (Frankincense) Oil, Commiphora Myrrha (Myrrh) Oil,Tocopheryl Acetate.

Questions Or Comments? (Questions or comments?)

1-877-917-9674

M-F, 9am-5pm EST or www.frankincensemyrrh.com


Advanced Ingredient Data


Raw Label Data

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