Label: SIERRASIL PAIN RELIEF- camphor spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 14, 2018

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  • 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

    Sierrasilcarton

  • INGREDIENTS AND APPEARANCE
    SIERRASIL PAIN RELIEF 
    camphor spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72608-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72608-002-301 in 1 CARTON10/01/2017
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2017
    Labeler - D&d Essential Oils, Llc. (051894458)
    Establishment
    NameAddressID/FEIBusiness Operations
    D&d Essential Oils, Llc.,051894458manufacture(72608-002)
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