Shield and Heal Lip Balm: Package Insert and Label Information

SHIELD AND HEAL LIP BALM- menthol
Shield and Heal Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Menthol 1%

Purpose

External analgesic

Use

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

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.

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.

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.

Product Packaging

Established Pharmacological Class

Substance Pharmacological Class Shield and Heal Botanical Lip Balm Lipstick

SHIELD AND HEAL LIP BALM menthol kit

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81470-002

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:81470-002-01 1 KIT in 1 KIT None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 4.25 g Part 2 1 TUBE 4.25 g

Part 1 of 2 SHIELD AND HEAL MEDICATED LIP BALM menthol stick

Product Information Item Code (Source) NDC:81470-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 10 mg in 1 g

Inactive Ingredients Ingredient Name Strength 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

Packaging # Item Code Package Description Multilevel Packaging 1 2 TUBE in 1 KIT contains a TUBE 1 4.25 g in 1 TUBE This package is contained within the KIT

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/15/2021

Part 2 of 2 SHIELD AND HEAL BOTANICAL LIP BALM stick

Product Information Route of Administration TOPICAL DEA Schedule

Ingredients Ingredient Name Quantity SYNTHETIC BEESWAX CARNAUBA WAX SHEA BUTTER BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES ORANGE OIL COCONUT OIL KARUM SEED OIL GARCINIA INDICA SEED BUTTER LAVENDER OIL GLYCERIN WATER CASTOR OIL GLYCERYL LAURATE SUNFLOWER OIL LANOLIN EUCALYPTUS OIL .ALPHA.-TOCOPHEROL ACETATE CANDELILLA WAX ACHILLEA MILLEFOLIUM FLOWER HIPPOPHAE RHAMNOIDES FRUIT OIL JOJOBA OIL PROPOLIS WAX

Packaging # Item Code Package Description Multilevel Packaging 1 2 TUBE in 1 KIT contains a TUBE 1 4.25 g in 1 TUBE This package is contained within the KIT

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 02/15/2021

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/15/2021

Labeler — Shield and Heal Inc. (117700988)

Revised: 04/2023 Shield and Heal Inc.