SPL v4
SPL
SPL Set ID 2ed25286-b077-1af2-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (1 g)
Inactive Ingredients
Mineral Oil Ethylparaben Trolamine Ilex Pubescens Root Pheretima Aspergillum Stearic Acid Aralia Chinensis Whole Oldenlandia Diffusa Pinus Massoniana Leaf Ampelopsis Glandulosa Var. Brevipedunculata Fruit Glycerin Dimethyl Sulfoxide Lanolin Maclura Cochinchinensis Root Petrolatum Sophora Flavescens Root Drynaria Fortunei Root Adina Rubella Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-30

Description

Camphor 1%


Medication Information

Warnings and Precautions

For extenal use only

Do not use:

-on wounds

-on irritated or damaged skin

-otherwise than as directed

When using this product:

-avoid contact with the eyes or mucous membranes

-do not bandage tightly

Indications and Usage

Temporarily relieves minor aches and pains of muscles and joints associate with:

-simple backache

-arthritis

-strains

-bruises

-spains

Dosage and Administration

-adults and children 3 years of age and older: apply 3 or 4 drops of medicate oil to the affecte area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and ten massaged as shown in the illustrations.

-Children under 3 years of age, consult your physician

-refer to the above warning; otherwise than as directed may be dangerous

Description

Camphor 1%

Section 50565-1

Children under 2 years of age: consult a doctor.

Section 51727-6

Yellow Vaseline

Wool Grease

Liquid Paraffin

Stearic Acid

Glycerol

Triethanolamine

Ethylparaben

Dimethyl Sulfoxide

Radix Illcis Pubescentis

Cortex Araliae

Pheretima

Herba Hedyotis Chrysotricae

Radix Pini Massonianae

Sophorae Flavescentis Radix

Drynariae Rhizoma

Radix Adinae Rubellae

Radix Cudraniae Cochinchinensis

Root from Itea Oblonga Hand.-Mazz

Root from Syzygium Grijsii (Hance) Merr. Et

Perry & Root from Ampelopsis Sinica (Miq) W.T. Wang & Root from Ormosia Henryi Prain & Cuscuta Japonica Choisy

Section 55105-1

External Analgesic

Topical Analgesic

Pain relieving cream

Section 55106-9

Camphor 1%

Pain Relief Cream


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves minor aches and pains of muscles and joints associate with:

-simple backache

-arthritis

-strains

-bruises

-spains

Dosage and Administration (34068-7)

-adults and children 3 years of age and older: apply 3 or 4 drops of medicate oil to the affecte area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and ten massaged as shown in the illustrations.

-Children under 3 years of age, consult your physician

-refer to the above warning; otherwise than as directed may be dangerous

Warnings and Precautions (34071-1)

For extenal use only

Do not use:

-on wounds

-on irritated or damaged skin

-otherwise than as directed

When using this product:

-avoid contact with the eyes or mucous membranes

-do not bandage tightly

Section 50565-1 (50565-1)

Children under 2 years of age: consult a doctor.

Section 51727-6 (51727-6)

Yellow Vaseline

Wool Grease

Liquid Paraffin

Stearic Acid

Glycerol

Triethanolamine

Ethylparaben

Dimethyl Sulfoxide

Radix Illcis Pubescentis

Cortex Araliae

Pheretima

Herba Hedyotis Chrysotricae

Radix Pini Massonianae

Sophorae Flavescentis Radix

Drynariae Rhizoma

Radix Adinae Rubellae

Radix Cudraniae Cochinchinensis

Root from Itea Oblonga Hand.-Mazz

Root from Syzygium Grijsii (Hance) Merr. Et

Perry & Root from Ampelopsis Sinica (Miq) W.T. Wang & Root from Ormosia Henryi Prain & Cuscuta Japonica Choisy

Section 55105-1 (55105-1)

External Analgesic

Topical Analgesic

Pain relieving cream

Section 55106-9 (55106-9)

Camphor 1%

Pain Relief Cream


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)