SIERRASIL PAIN RELIEF- camphor spray

SierraSil by

Drug Labeling and Warnings

SierraSil by is a Otc medication manufactured, distributed, or labeled by Sierra Mountain Minerals Inc. d/b/a Sierra Sil Health Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor (3.1%)

PURPOSE

External analgesic

INDICATIONS & USAGE

Uses:

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

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

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

WHEN USING

When using this product, use only as directed

Do not bandage tightly

Avoid contact with eyes and mucous membranes

ASK DOCTOR

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

PREGNANCY OR BREAST FEEDING

Pregnant women should consult their physician before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DOSAGE & 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.

INACTIVE INGREDIENT

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

QUESTIONS

Questions?

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

STORAGE AND HANDLING

Shake well before use

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

SIERRASIL  PAIN RELIEF
camphor spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50802-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727)	CAMPHOR OIL	1 mL  in 30 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50802-001-30	30 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	03/01/2010

Labeler - Sierra Mountain Minerals Inc. d/b/a Sierra Sil Health Inc. (829616213)

Registrant - Sierra Mountain Minerals Inc. d/b/a Sierra Sil Health Inc. (829616213)

Establishment
Name	Address	ID/FEI	Business Operations
Sierra Mountain Minerals Inc. d/b/a Sierra Sil Health Inc.		829616213	relabel