shield + heal lip balm kit

shield + heal lip balm kit
SPL v3
SPL
SPL Set ID ba5eed7d-211e-25ef-e053-2995a90a159c
Route
topical
Published
Effective Date 2021-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (10 mg)
Inactive Ingredients
synthetic beeswax carnauba wax shea butter butyrospermum parkii (shea) butter unsaponifiables oatmeal orange oil coconut oil karum seed oil garcinia indica seed butter lavender oil glycerin water castor oil glyceryl laurate sunflower oil lanolin camphor (synthetic) eucalyptus oil .alpha.-tocopherol acetate candelilla wax achillea millefolium flower hippophae rhamnoides fruit oil jojoba oil propolis wax

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-02-15

Purpose

External analgesic

Description

Menthol 1%


Medication Information

Warnings

For external use only.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Purpose

External analgesic

Directions
  • children under 2 years of age: consult a doctor.
  • adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
Other Information
  • Store at room temperature and avoid excessive heat.
Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil, Moringa Oil/Hydrogenated Moringa Oil Esters, Synthetic Beeswax, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera Cera, Ricinus Communis (Castor) Seed Oil, Lanolin, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter Unsaponifiables, Camphor, Avena Sativa (Oat) Kernel Flour, Butyrospermum Parkii (Shea Butter), Citrus Aurantium Dulcis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus Leaf Oil, Garcinia Indica Seed Butter, Glyceryl Laurate, Hippophae Rhamnoides (Sea Buckthorn) Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Pongamia Glabra Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Propolis Extract, Water, Achillea Millefolium Flower Extract.

Description

Menthol 1%

Use

for the temporary relief of pain and itching associated with fever blisters and cold sores.

Active Ingredient

Menthol 1%

Product Packaging

When Using This Product

avoid contact with eyes.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Purpose

External analgesic

Directions
  • children under 2 years of age: consult a doctor.
  • adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
Other Information (Other information)
  • Store at room temperature and avoid excessive heat.
Inactive Ingredients (Inactive ingredients)

Helianthus Annuus (Sunflower) Seed Oil, Moringa Oil/Hydrogenated Moringa Oil Esters, Synthetic Beeswax, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera Cera, Ricinus Communis (Castor) Seed Oil, Lanolin, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter Unsaponifiables, Camphor, Avena Sativa (Oat) Kernel Flour, Butyrospermum Parkii (Shea Butter), Citrus Aurantium Dulcis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus Leaf Oil, Garcinia Indica Seed Butter, Glyceryl Laurate, Hippophae Rhamnoides (Sea Buckthorn) Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Pongamia Glabra Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Propolis Extract, Water, Achillea Millefolium Flower Extract.

Use

for the temporary relief of pain and itching associated with fever blisters and cold sores.

Active Ingredient (Active ingredient)

Menthol 1%

Product Packaging

When Using This Product (When using this product)

avoid contact with eyes.

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

All Sections (JSON)