Sweet Balm by isamogu Inc. / Isamogu Inc. Sweet Balm 82690-302

Sweet Balm by

Drug Labeling and Warnings

Sweet Balm by is a Otc medication manufactured, distributed, or labeled by isamogu Inc., Isamogu Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SWEET BALM- peppermint oil stick 
isamogu Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Sweet Balm 82690-302

Active Ingredient

Peppermint Oil 0.65%

Purpose

nasal decongestion

Use

Temporary relief of nasal congestion.

Warnings

Do not use in or near the wounded areas.

Warnings

When using this product do not use in or near the eyes.

Warnings

Stop use and ask a doctor if irritation or rash appears and lasts.

Warnings

Keep out of reach of children.

Warnings

In case of contact, rinse eyes thoroughly with water.

Directions

Adults and children 6 months and over.

Apply to right below the nostrils.

Allow to dry without wiping.

Inactive Ingredients

Prunus AmygdalusDulcis (Sweet Almond) Oil, Butyrospermum Parkii (Shea) Butter, Beeswax, Eucalyptus Globulus Leaf Oil, Tocophery Acetate, Limonene, Linalool, Camellia Japonica Seed Oil, Cocos Nucifera (Coconut) Oil, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Macadamia Ternifolia Seed Oil, Prunus Armeniaca(Apricot) Kernel Oil, Moringa Oleifera Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Squalane, Vitis vinifera (Grape) seed oil, Chamaecyparis Obtusa Leaf Extract, Ginkgo Biloba Leaf Extract, Butylene Glycol, 1,2-Hexanediol

Sweet Balm Label

SWEET BALM 
peppermint oil stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82690-302
Route of Administration	TOPICAL, RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B)	PEPPERMINT OIL	0.65 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ALMOND OIL (UNII: 66YXD4DKO9)
SHEA BUTTER (UNII: K49155WL9Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MACADAMIA OIL (UNII: 515610SU8C)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
SQUALANE (UNII: GW89575KF9)
GRAPE SEED OIL (UNII: 930MLC8XGG)
GINKGO (UNII: 19FUJ2C58T)
JOJOBA OIL (UNII: 724GKU717M)
TOMATO SEED OIL (UNII: 7N87T9C06T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82690-302-01	4.3 g in 1 TUBE; Type 0: Not a Combination Product	05/03/2022	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/03/2022	07/29/2024

Labeler - isamogu Inc. (695695834)

Registrant - isamogu Inc. (695695834)

Establishment
Name	Address	ID/FEI	Business Operations
Isamogu Inc.		695695834	manufacture(82690-302)

Revised: 7/2024

Document Id: 1e6498ea-b45b-8260-e063-6294a90a4fbb

34390-5

Set id: de1330ee-03c0-fdd9-e053-2995a90a17da

Version: 2

Effective Time: 20240729

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