EARTHMED LIP BALM PINEAPPLE- allantoin salve EARTHMED LIP BALM PEPPERMINT- allantoin salve EARTHMED LIP BALM STRAWBERRY- allantoin salve EARTHMED LIP BALM STRAWBERRY RHUBARB- allantoin salve EARTHMED LIP BALM UNFLAVORED- allantoin salve

Earthmed Lip Balm unflavored by

Drug Labeling and Warnings

Earthmed Lip Balm unflavored by is a Otc medication manufactured, distributed, or labeled by Earthmed LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

Purpose

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

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

Warnings

FOR EXTERNAL USE ONLY.

When using this product

Do not get into eyes

on deep or puncture wounds animal bites serious burns

Stop use and ask a doctor if

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

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

If pregnant or breastfeeding

Consult a health professional before use

In case of an overdose

seek medical help or contact a poison control center right away

Directions

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

Keep out of reach of children

keep out of reach of children

Other information

Store at 68-77 degrees F, Avoid direct sunlight

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EARTHMED LIP BALM PINEAPPLE 
allantoin salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82876-988
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.045 g  in 4.455 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)	1.23 g  in 4.455 g
REBAUDIOSIDE A (UNII: B3FUD0528F)	0.075 g  in 4.455 g
ALCOHOL (UNII: 3K9958V90M)	0.075 g  in 4.455 g
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)	0.85 g  in 4.455 g
ALMOND OIL (UNII: 66YXD4DKO9)	0.9 g  in 4.455 g
RICE BRAN OIL (UNII: LZO6K1506A)	0.9 g  in 4.455 g
CANNABIDIOL (UNII: 19GBJ60SN5)	0.21 g  in 4.455 g

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82876-988-01	4.455 g in 1 TUBE; Type 0: Not a Combination Product	08/05/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/05/2025

EARTHMED LIP BALM PEPPERMINT 
allantoin salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82876-990
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.045 g  in 4.455 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)	1.23 g  in 4.455 g
REBAUDIOSIDE A (UNII: B3FUD0528F)	0.075 g  in 4.455 g
ALCOHOL (UNII: 3K9958V90M)	0.075 g  in 4.455 g
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)	0.85 g  in 4.455 g
ALMOND OIL (UNII: 66YXD4DKO9)	0.9 g  in 4.455 g
RICE BRAN OIL (UNII: LZO6K1506A)	0.9 g  in 4.455 g
CANNABIDIOL (UNII: 19GBJ60SN5)	0.21 g  in 4.455 g

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82876-990-01	4.455 g in 1 TUBE; Type 0: Not a Combination Product	08/05/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/05/2025

EARTHMED LIP BALM STRAWBERRY 
allantoin salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82876-991
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.045 g  in 4.455 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)	1.23 g  in 4.455 g
REBAUDIOSIDE A (UNII: B3FUD0528F)	0.075 g  in 4.455 g
ALCOHOL (UNII: 3K9958V90M)	0.075 g  in 4.455 g
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)	0.85 g  in 4.455 g
ALMOND OIL (UNII: 66YXD4DKO9)	0.9 g  in 4.455 g
RICE BRAN OIL (UNII: LZO6K1506A)	0.9 g  in 4.455 g
CANNABIDIOL (UNII: 19GBJ60SN5)	0.21 g  in 4.455 g

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82876-991-01	4.455 g in 1 TUBE; Type 0: Not a Combination Product	08/05/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/05/2025

EARTHMED LIP BALM STRAWBERRY RHUBARB 
allantoin salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82876-987
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.045 g  in 4.455 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)	1.23 g  in 4.455 g
REBAUDIOSIDE A (UNII: B3FUD0528F)	0.075 g  in 4.455 g
ALCOHOL (UNII: 3K9958V90M)	0.075 g  in 4.455 g
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)	0.85 g  in 4.455 g
ALMOND OIL (UNII: 66YXD4DKO9)	0.9 g  in 4.455 g
RICE BRAN OIL (UNII: LZO6K1506A)	0.9 g  in 4.455 g
CANNABIDIOL (UNII: 19GBJ60SN5)	0.21 g  in 4.455 g

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	STRAWBERRY (Strawberry rhubarb flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82876-987-01	4.455 g in 1 TUBE; Type 0: Not a Combination Product	08/05/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/05/2025

EARTHMED LIP BALM UNFLAVORED 
allantoin salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82876-989
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.045 g  in 4.455 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)	1.23 g  in 4.455 g
REBAUDIOSIDE A (UNII: B3FUD0528F)	0.075 g  in 4.455 g
ALCOHOL (UNII: 3K9958V90M)	0.075 g  in 4.455 g
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)	0.85 g  in 4.455 g
ALMOND OIL (UNII: 66YXD4DKO9)	0.9 g  in 4.455 g
RICE BRAN OIL (UNII: LZO6K1506A)	0.9 g  in 4.455 g
CANNABIDIOL (UNII: 19GBJ60SN5)	0.21 g  in 4.455 g

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82876-989-01	4.455 g in 1 TUBE; Type 0: Not a Combination Product	08/05/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/05/2025

Labeler - Earthmed LLC (118697474)

Registrant - Earthmed LLC (118697474)

Establishment
Name	Address	ID/FEI	Business Operations
Earthmed LLC		118697474	manufacture(82876-991, 82876-990, 82876-989, 82876-988, 82876-987)