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.

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Shield + Heal Lip Balm Kit

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

Other information

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

4 pack

SHIELD AND HEAL LIP BALM 
menthol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81470-002
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81470-002-011 in 1 KIT; Type 0: Not a Combination Product02/15/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 4.25 g
Part 21 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 KIT
14.25 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/15/2021
Part 2 of 2
SHIELD AND HEAL BOTANICAL LIP BALM 
lipstick stick
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
INGRCARNAUBA WAX (UNII: R12CBM0EIZ)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRBUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
INGRORANGE OIL (UNII: AKN3KSD11B)  
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRKARUM SEED OIL (UNII: 62160PU6FJ)  
INGRGARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRWATER (UNII: 059QF0KO0R)  
INGRCASTOR OIL (UNII: D5340Y2I9G)  
INGRGLYCERYL LAURATE (UNII: Y98611C087)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGRLANOLIN (UNII: 7EV65EAW6H)  
INGREUCALYPTUS OIL (UNII: 2R04ONI662)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRCANDELILLA WAX (UNII: WL0328HX19)  
INGRACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
INGRHIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
INGRJOJOBA OIL (UNII: 724GKU717M)  
INGRPROPOLIS WAX (UNII: 6Y8XYV2NOF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 KIT
14.25 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic02/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/15/2021
Labeler - Shield and Heal Inc. (117700988)

Revised: 4/2023
Document Id: fa53f692-e689-97ed-e053-6294a90a1763
Set id: ba5eed7d-211e-25ef-e053-2995a90a159c
Version: 3
Effective Time: 20230427
 
Shield and Heal Inc.