SPL v1
SPL
SPL Set ID b8685885-f733-4f03-b08c-09e53f57afeb
Route
TOPICAL
Published
Effective Date 2010-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor Oil (1 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-03-01

Description

Camphor (3.1%)


Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY

Indications and Usage

Uses:

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

Dosage and Administration

Adults and children 2 yrs of age and older:  Apply to affected area not more than 3 to 4 times daily.

Children under 2 yrs of age:  Do not use, consult a doctor.

Description

Camphor (3.1%)

Section 44425-7

Shake well before use

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Section 50567-7

When using this product, use only as directed

Do not bandage tightly

Avoid contact with eyes and mucous membranes

Section 50569-3

Stop and ask doctor if conditions worsens, symptoms last for more than 7 days, or symptoms clear up and come back in a few days

Section 50570-1

Do not use for arthritis-like conditions in children under 2

Do not use with a heating pad

Do not apply to wounds, damaged, broken or irritated skin

Section 51727-6

Aloe vera oil, Eucalyptus oil, Lavender oil, Lemon oil, Orange oil, Peppermint oil, Rosemary oil, and SierraSil

Section 51945-4

Sierra Sil

Pain Relief

Health You Can Feel

Temporarily relieves minor aches and pains





Product of USA



Manufactured under US patent number 6,444,238 B1 by Swiss Medica Inc.



Distributed by SierraSil Health Inc., Vancouver, B.C. V6J 4Z6 Canada





Section 53413-1

Questions?

Visit www.sierrasil.com or call toll free 1-877-743-7720

Section 53414-9

Pregnant women should consult their physician before use

Section 55105-1

External analgesic

Section 55106-9

Camphor (3.1%)


Structured Label Content

Indications and Usage (34067-9)

Uses:

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

Dosage and Administration (34068-7)

Adults and children 2 yrs of age and older:  Apply to affected area not more than 3 to 4 times daily.

Children under 2 yrs of age:  Do not use, consult a doctor.

Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY

Section 44425-7 (44425-7)

Shake well before use

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Section 50567-7 (50567-7)

When using this product, use only as directed

Do not bandage tightly

Avoid contact with eyes and mucous membranes

Section 50569-3 (50569-3)

Stop and ask doctor if conditions worsens, symptoms last for more than 7 days, or symptoms clear up and come back in a few days

Section 50570-1 (50570-1)

Do not use for arthritis-like conditions in children under 2

Do not use with a heating pad

Do not apply to wounds, damaged, broken or irritated skin

Section 51727-6 (51727-6)

Aloe vera oil, Eucalyptus oil, Lavender oil, Lemon oil, Orange oil, Peppermint oil, Rosemary oil, and SierraSil

Section 51945-4 (51945-4)

Sierra Sil

Pain Relief

Health You Can Feel

Temporarily relieves minor aches and pains





Product of USA



Manufactured under US patent number 6,444,238 B1 by Swiss Medica Inc.



Distributed by SierraSil Health Inc., Vancouver, B.C. V6J 4Z6 Canada





Section 53413-1 (53413-1)

Questions?

Visit www.sierrasil.com or call toll free 1-877-743-7720

Section 53414-9 (53414-9)

Pregnant women should consult their physician before use

Section 55105-1 (55105-1)

External analgesic

Section 55106-9 (55106-9)

Camphor (3.1%)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)