SWEET BALM- peppermint oil stick 
isamogu 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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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_Drug Facts Label

SWEET BALM 
peppermint oil stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82690-302
Route of AdministrationTOPICAL, RESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL0.65 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82690-302-014.3 g in 1 TUBE; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/03/2022
Labeler - isamogu Inc. (695695834)
Registrant - isamogu Inc. (695695834)
Establishment
NameAddressID/FEIBusiness Operations
Isamogu Inc.695695834manufacture(82690-302)

Revised: 5/2022
Document Id: de1330ee-03c1-fdd9-e053-2995a90a17da
Set id: de1330ee-03c0-fdd9-e053-2995a90a17da
Version: 1
Effective Time: 20220502
 
isamogu Inc.