SHIELD AND HEAL LIP BALM- menthol kit

Shield and Heal Lip Balm by

Drug Labeling and Warnings

Shield and Heal Lip Balm by is a Otc medication manufactured, distributed, or labeled by Shield and Heal Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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	Marketing Start Date	Marketing End Date
1	NDC: 81470-002-01	1 in 1 KIT; Type 0: Not a Combination Product	02/15/2021

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
OATMEAL (UNII: 8PI54V663Y)
ORANGE OIL (UNII: AKN3KSD11B)
COCONUT OIL (UNII: Q9L0O73W7L)
KARUM SEED OIL (UNII: 62160PU6FJ)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERYL LAURATE (UNII: Y98611C087)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LANOLIN (UNII: 7EV65EAW6H)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
EUCALYPTUS OIL (UNII: 2R04ONI662)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CANDELILLA WAX (UNII: WL0328HX19)
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
JOJOBA OIL (UNII: 724GKU717M)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 KIT
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

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 
lipstick stick

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
INGR	CARNAUBA WAX (UNII: R12CBM0EIZ)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
INGR	ORANGE OIL (UNII: AKN3KSD11B)
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	KARUM SEED OIL (UNII: 62160PU6FJ)
INGR	GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
INGR	LAVENDER OIL (UNII: ZBP1YXW0H8)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	WATER (UNII: 059QF0KO0R)
INGR	CASTOR OIL (UNII: D5340Y2I9G)
INGR	GLYCERYL LAURATE (UNII: Y98611C087)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	LANOLIN (UNII: 7EV65EAW6H)
INGR	EUCALYPTUS OIL (UNII: 2R04ONI662)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	CANDELILLA WAX (UNII: WL0328HX19)
INGR	ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)
INGR	HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
INGR	JOJOBA OIL (UNII: 724GKU717M)
INGR	PROPOLIS WAX (UNII: 6Y8XYV2NOF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 KIT
1		4.25 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

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)