SIERRASIL PAIN RELIEF- camphor spray

SierraSil Pain Relief by

Drug Labeling and Warnings

SierraSil Pain Relief by is a Otc medication manufactured, distributed, or labeled by O24 Naturals, LLC, D&d Essential Oils, Llc.,, Biomed Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Camphor 3.1%

Purpose

Camphor 3.1%.........................................Topical analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

For external use only.

Do not

• apply to wounds or damaged skin
• bandage tightly
• use with a heating pad
  

When using this product

• avoid contact with eyes or mucous membranes
• use only as directed
  

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
  

If pregnant or breast feeding, ask a health care professional before use.

Keep out of reach of children.

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

Directions

• 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: consult a doctor.
  

Other Information

• shake well before use.
  

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Hydrothermal Mineral Complex (SierraSil), Lavandula Angustifolia (Lavender) Oil, Mentha arvensis (Peppermint) Oil, Rosmarinus Officinalis Leaf (Rosemary) Oil

Questions?

Visit www.sierrasil.com or call toll free 1-877-743-7720 Monday-Friday 8:00am to 4:30pm

DESCRIPTION

Distributed by SierraSil Health Inc.

1500 NW Bethany Blvd Suite 200,

Beaverton, OR, 97006

Principal Display Panel

SierraSil

Pain

Relief

TOPICAL

ANALGESIC

SPRAY

TEMPORARILY

RELIEVES

MINOR ACHES

AND PAINS

1 fl oz / 30 mL

INGREDIENTS AND APPEARANCE

SIERRASIL PAIN RELIEF 
camphor spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58265-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ORANGE OIL (UNII: AKN3KSD11B)
LEMON OIL (UNII: I9GRO824LL)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)
ROSEMARY OIL (UNII: 8LGU7VM393)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58265-002-30	1 in 1 CARTON	02/01/2013
1		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2013

Labeler - O24 Naturals, LLC (962526559)

Establishment
Name	Address	ID/FEI	Business Operations
D&d Essential Oils, Llc.,		051894458	manufacture(58265-002)

Establishment
Name	Address	ID/FEI	Business Operations
Biomed Laboratories LLC		055329696	label(58265-002)