FDA.reportPublic FDA data

Shield and Heal Medicated Lip Balm

Manufacturer
Shield and Heal Inc.
Effective date
2023-04-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:47

Label at a glance#

ProductShield and Heal Medicated Lip Balm
Active ingredientMENTHOL
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1%

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

avoid contact with eyes.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

  • Store at room temperature and avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 pack1 pack

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81470-001-012025-01-30C16284748780-1f386c649-bdb4-0266-e053-dadaa90a7c1aShield + Heal Medicated Lip Balm
81470-001-022025-01-30C16284748780-1f386c649-bdb4-0266-e053-dadaa90a7c1aShield + Heal Medicated Lip Balm
81470-001-012023-04-27C16284748780-1f386c649-bdb4-0266-e053-dadaa90a7c1aShield + Heal Medicated Lip Balm
81470-001-022023-04-27C16284748780-1f386c649-bdb4-0266-e053-dadaa90a7c1aShield + Heal Medicated Lip Balm
81470-001-012023-01-30C16284748780-1f386c649-bdb4-0266-e053-dadaa90a7c1aShield + Heal Medicated Lip Balm
81470-001-022023-01-30C16284748780-1f386c649-bdb4-0266-e053-dadaa90a7c1aShield + Heal Medicated Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81470-001-01Shield and Heal Medicated Lip Balm1 in 1 CARTONSTICK13
81470-001-01Shield and Heal Medicated Lip Balm4.25 g in 1 TUBESTICK4.253
81470-001-02Shield and Heal Medicated Lip Balm2 in 1 CARTONSTICK23
81470-001-02Shield and Heal Medicated Lip Balm4.25 g in 1 TUBESTICK4.253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81470-001SHIELD AND HEAL MEDICATED LIP BALM (MENTHOL) STICK [SHIELD AND HEAL INC.]3Legacy NDC, 4 package rows20230428_b9bf16a5-7848-44bc-e053-2995a90ade44.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81470-00181470-001-01, 81470-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL LAURATEY98611C087IACT
CASTOR OILD5340Y2I9GIACT
ORANGE OILAKN3KSD11BIACT
JOJOBA OIL724GKU717MIACT
ACHILLEA MILLEFOLIUM WHOLE2FXJ6SW4PKIACT
LAVENDER OILZBP1YXW0H8IACT
WATER059QF0KO0RIACT
GARCINIA INDICA SEED BUTTERUS2H3D7800IACT
PROPOLIS WAX6Y8XYV2NOFIACT
SUNFLOWER OIL3W1JG795YIIACT
CANDELILLA WAXWL0328HX19IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
CARNAUBA WAXR12CBM0EIZIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
TOCOPHEROLR0ZB2556P8IACT
COCONUT OILQ9L0O73W7LIACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
GLYCERINPDC6A3C0OXIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
KARUM SEED OIL62160PU6FJIACT
OATMEAL8PI54V663YIACT
LANOLIN7EV65EAW6HIACT
SHEA BUTTERK49155WL9YIACT
EUCALYPTUS OIL2R04ONI662IACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fa540c14-3c0e-d3a0-e053-6394a90a4e3db9bf16a5-7848-44bc-e053-2995a90ade442023-04-27WarningsExact identifier
spl id: fa540c14-3c0e-d3a0-e053-6394a90a4e3d
spl set id: b9bf16a5-7848-44bc-e053-2995a90ade44

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.