Sore No More

Sore No More
SPL v6
SPL
SPL Set ID 80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd
Route
TOPICAL
Published
Effective Date 2016-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.03 g) Camphor (synthetic)
Inactive Ingredients
Aloe Vera Leaf Capsicum Carbomer Homopolymer Type C Decyl Glucoside Water Grapefruit Seed Oil Green Tea Leaf Orange Peel Filipendula Ulmaria Flower Rosa Centifolia Flower Oil Sodium Hydroxymethylglycinate Glycerin Witch Hazel Yucca Schidigera Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-10-25

Description

Menthol USP 3% Camphor USP 3%

Purpose

Purpose External Analgesic


Medication Information

Purpose

PurposeExternal Analgesic

Description

Menthol USP 3% Camphor USP 3%

Uses

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

Section 51945-4

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.

Active Ingredients

Menthol USP 3%

Camphor USP 3%

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 

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

Purpose

PurposeExternal Analgesic

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.

Active Ingredients

Menthol USP 3%

Camphor USP 3%

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 (Questions or Comments)

1-800-842-6622 

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)