MUSCLE EASE- menthol camphor gel 
SOMBRA COSMETICS 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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Muscle Ease

Active Ingredients

Menthol USP 3%

Camphor USP 3%

Purpose

PURPOSE EXTERNAL ANALGESIC

Keep out of reach of children

Keep out of reach of children

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, arthritis, strains, bruises, and sprains

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

Aloe Barbadensis leaf Juice, Camellia Sinensis (Green Tea) Leaf Extract, Caprylyl Glycol, Capsicum Annuum Fruit Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Filipendula Ulmaria (Queen of the Praire) Flower Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Phenoxyethanol, Purified Water, Rosa Damascena Flower Water, Sodium Carbonate, Yucca Schidigera Stem Extract.

Questions or Comments

1-800-225-3963

label

MUSCLE EASE 
menthol camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-2301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.03 g  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAPSICUM (UNII: 00UK7646FG)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
WATER (UNII: 059QF0KO0R)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ORANGE PEEL (UNII: TI9T76XD44)  
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
GLYCERIN (UNII: PDC6A3C0OX)  
WITCH HAZEL (UNII: 101I4J0U34)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-2301-4113.4 g in 1 JAR; Type 0: Not a Combination Product02/14/2023
2NDC:61577-2301-256.7 g in 1 TUBE; Type 0: Not a Combination Product02/14/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/14/2023
Labeler - SOMBRA COSMETICS INC. (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS INC.097464309manufacture(61577-2301) , label(61577-2301)

Revised: 2/2023
Document Id: b78a84a7-a36e-4715-b50c-2b96adedc506
Set id: 03fff4bf-04ed-49a6-b40f-4d98c2b42f69
Version: 6
Effective Time: 20230214
 
SOMBRA COSMETICS INC.