SORE NO MORE- 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.

----------

SORE NO MORE

Active Ingredients

Menthol USP 3%

Camphor USP 3%

Purpose

External Analgesic

Keep out of reach of children

Keep out of reach of children

Uses

Temporarily relieves minor aches, pains, inflammation and sor muscles associated with stiffness, arthritis, and injuries

Warnings

For external use only. Avoid contact with eyes, mucous membranes, damaged skin. Do not use with heating pads, avoid bandaging tightly.

Stop use and ask doctor if: symptoms persist

Directions

adults and children 2 years of age and older: apply to affected area liberally up to 4 times daily. Avoid contact with eyes. Wash hands after use.

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, Glycerin,
Hamamelis Virginiana (Witch Hazel) Leaf Extract, Phenoxyethanol,
Purified Water, Rosa Damascena Flower Water, Sodium Carbonate,
Spiraea Ulmaria Flower (Queen of the Prairie) Extract, Yucca
Schidigera Root Extract

Questions or Comments

1-800-842-6622

image description

SORE NO MORE 
menthol camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-2280
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)  
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ORANGE PEEL (UNII: TI9T76XD44)  
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
GLYCERIN (UNII: PDC6A3C0OX)  
WITCH HAZEL (UNII: 101I4J0U34)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-2280-55 g in 1 POUCH; Type 0: Not a Combination Product03/08/2023
2NDC:61577-2280-258.7 g in 1 JAR; Type 0: Not a Combination Product03/08/2023
3NDC:61577-2280-4113.4 g in 1 JAR; Type 0: Not a Combination Product03/08/2023
4NDC:61577-2280-8226.8 g in 1 JAR; Type 0: Not a Combination Product03/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/08/2023
Labeler - SOMBRA COSMETICS INC. (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS INC.097464309manufacture(61577-2280) , label(61577-2280)

Revised: 3/2023
Document Id: 7cbef24a-b265-4235-8613-ceb45b9d874a
Set id: 80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd
Version: 5
Effective Time: 20230308
 
SOMBRA COSMETICS INC.