SORE NO MORE- menthol camphor gel

SORE NO MORE by

Drug Labeling and Warnings

SORE NO MORE by is a Otc medication manufactured, distributed, or labeled by SOMBRA COSMETICS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol USP 3%

Camphor USP 3%

Purpose

PurposeExternal 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 

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SORE NO MORE 
menthol camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-2280
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.03 g  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-2280-5	5 g in 1 POUCH; Type 0: Not a Combination Product	10/25/2016
2	NDC: 61577-2280-2	58.7 g in 1 JAR; Type 0: Not a Combination Product	10/25/2016
3	NDC: 61577-2280-4	113.4 g in 1 JAR; Type 0: Not a Combination Product	10/25/2016
4	NDC: 61577-2280-8	226.8 g in 1 JAR; Type 0: Not a Combination Product	10/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/25/2016

Labeler - SOMBRA COSMETICS INC. (097464309)

Registrant - SOMBRA COSMETICS INC. (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
SOMBRA COSMETICS INC.		097464309	manufacture(61577-2280) , label(61577-2280)