SHIELD AND HEAL MEDICATED LIP BALM- menthol stick

Shield and Heal Medicated Lip Balm by

Drug Labeling and Warnings

Shield and Heal Medicated 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

• adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• children under 2 years of age: consult a doctor.

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.

QUESTIONS

Call toll free 888-933-3253 or learn more at www.shieldandheal.com

Product Packaging

INGREDIENTS AND APPEARANCE

SHIELD AND HEAL MEDICATED LIP BALM 
menthol stick

Product Information
Product Type	HUMAN OTC DRUG	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
GLYCERYL LAURATE (UNII: Y98611C087)
CASTOR OIL (UNII: D5340Y2I9G)
ORANGE OIL (UNII: AKN3KSD11B)
JOJOBA OIL (UNII: 724GKU717M)
ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)
LAVENDER OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CANDELILLA WAX (UNII: WL0328HX19)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
CARNAUBA WAX (UNII: R12CBM0EIZ)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
GLYCERIN (UNII: PDC6A3C0OX)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
KARUM SEED OIL (UNII: 62160PU6FJ)
OATMEAL (UNII: 8PI54V663Y)
LANOLIN (UNII: 7EV65EAW6H)
SHEA BUTTER (UNII: K49155WL9Y)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81470-001-01	1 in 1 CARTON	02/15/2021
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 81470-001-02	2 in 1 CARTON	02/15/2021
2		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

Labeler - Shield and Heal Inc. (117700988)