FDA.reportPublic FDA data

Earthmed Lip Balm unflavored

Manufacturer
Earthmed LLC
Effective date
2025-08-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:09:20

Label at a glance#

ProductEarthmed Lip Balm Pineapple
Active ingredientALLANTOIN
Label structure14 sections

Indications and uses

helps prevent and temporarily protects and helps relieve chafed, chapped, or cracked skin • helps prevent and protect from the drying effects of wind and cold weather

Dosage and administration

• Adults and children 2 years of age and older: Apply as needed • Children under 2 years of age: Do not use, consult a doctor keep out of reach of children keep out of reach of children

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 1% .................................................................................................. Skin Protectant

Purpose

OTC - PURPOSE SECTION

Allantoin 0.72% .................................................................................................. Skin Protectant

Uses

INDICATIONS & USAGE SECTION

helps prevent and temporarily protects and helps relieve chafed, chapped, or
cracked skin • helps prevent and protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

When using this product

OTC - WHEN USING SECTION

Do not get into eyes

OTC - DO NOT USE SECTION

on deep or puncture wounds • animal bites • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

The condition worsens, symptoms last more than 7 days, the condition clears but occurs again within a few days.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

Condition worsens, Symptoms last more than 7 days, Condition clears up but occurs again within a few days.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a health professional before use

In case of an overdose

OVERDOSAGE SECTION

seek medical help or contact a poison control center right away

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age and older: Apply as needed
• Children under 2 years of age: Do not use, consult a doctor

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

Other information

OTHER SAFETY INFORMATION

Store at 68-77 degrees F, Avoid direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Coconut oil, Ethanol, Full Spectrum Hemp oil, Natural Flavor, Sweet Almond oil,
Rice bran oil, Stevia extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

peppermint lip balmpeppermint lip balm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unflavored lip balmUnflavored lip balm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Strawberry rhubarb lip balmStrawberry rhubarb lip balm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pineapple lip balmPineapple lip balm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Strawberry lip balmStrawberry lip balm

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82876-987-01Earthmed Lip Balm Strawberry Rhubarb4.455 g in 1 TUBESALVE4.4552
82876-988-01Earthmed Lip Balm Pineapple4.455 g in 1 TUBESALVE4.4552
82876-989-01Earthmed Lip Balm unflavored4.455 g in 1 TUBESALVE4.4552
82876-990-01Earthmed Lip Balm peppermint4.455 g in 1 TUBESALVE4.4552
82876-991-01Earthmed Lip Balm Strawberry4.455 g in 1 TUBESALVE4.4552

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82876-99182876-991-01
82876-99082876-990-01
82876-98982876-989-01
82876-98882876-988-01
82876-98782876-987-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZACTIB
COCONUT OILQ9L0O73W7LIACT
REBAUDIOSIDE AB3FUD0528FIACT
ALCOHOL3K9958V90MIACT
PEG-8 BEESWAX3C1QUF1TIRIACT
ALMOND OIL66YXD4DKO9IACT
RICE BRAN OILLZO6K1506AIACT
CANNABIDIOL19GBJ60SN5IACT
ALLANTOIN344S277G0ZACTIB
COCONUT OILQ9L0O73W7LIACT
REBAUDIOSIDE AB3FUD0528FIACT
ALCOHOL3K9958V90MIACT
PEG-8 BEESWAX3C1QUF1TIRIACT
ALMOND OIL66YXD4DKO9IACT
RICE BRAN OILLZO6K1506AIACT
CANNABIDIOL19GBJ60SN5IACT
ALLANTOIN344S277G0ZACTIB
COCONUT OILQ9L0O73W7LIACT
REBAUDIOSIDE AB3FUD0528FIACT
ALCOHOL3K9958V90MIACT
PEG-8 BEESWAX3C1QUF1TIRIACT
ALMOND OIL66YXD4DKO9IACT
RICE BRAN OILLZO6K1506AIACT
CANNABIDIOL19GBJ60SN5IACT
ALLANTOIN344S277G0ZACTIB
COCONUT OILQ9L0O73W7LIACT
REBAUDIOSIDE AB3FUD0528FIACT
ALCOHOL3K9958V90MIACT
PEG-8 BEESWAX3C1QUF1TIRIACT
ALMOND OIL66YXD4DKO9IACT
RICE BRAN OILLZO6K1506AIACT
CANNABIDIOL19GBJ60SN5IACT
ALLANTOIN344S277G0ZACTIB
COCONUT OILQ9L0O73W7LIACT
REBAUDIOSIDE AB3FUD0528FIACT
ALCOHOL3K9958V90MIACT
PEG-8 BEESWAX3C1QUF1TIRIACT
ALMOND OIL66YXD4DKO9IACT
RICE BRAN OILLZO6K1506AIACT
CANNABIDIOL19GBJ60SN5IACT

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
Earthmed Lip Balm Strawberry RhubarbALLANTOINEarthmed LLC3b54eea1-2e09-2ee1-e063-6294a90a52e52025-08-05WarningsExact identifier
ndc (package): 82876-989-01
ndc (package): 82876-991-01
ndc (package): 82876-988-01
ndc (package): 82876-987-01
ndc (package): 82876-990-01
ndc (product): 82876-989
ndc (product): 82876-988
ndc (product): 82876-991
ndc (product): 82876-990
ndc (product): 82876-987
ndc11 (package): 82876098701
ndc11 (package): 82876098901
ndc11 (package): 82876098801
ndc11 (package): 82876099101
ndc11 (package): 82876099001
spl id: 3ba1f64c-5672-53c6-e063-6294a90adda4
spl set id: 3b54eea1-2e09-2ee1-e063-6294a90a52e5

Reported adverse events (FAERS/openFDA)#

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