Label: SOOTHE AND MOVE PAIN RELIEF CREAM- camphor cream

  • 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 November 23, 2021

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active Ingredients
    Camphor 3.18%

  • PURPOSE

    Purpose
    Topical Analgesic

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings:
    For External Use Only

  • DO NOT USE

    Do not use:
    ■ Other than as directed
    ■ 0n wounds or damaged
       skin
    ■ With a heating pad
    ■ If you are allergic to any
       ingredient in this product
    ■ 0n a child under 12 with
       arthritis-like conditions

  • WHEN USING

    When using this product:
    ■ Avoid contact with eyes, wounds,
    mucus membrane, irritated skin.
    ■ Do not bandage tightly.

  • STOP USE

    Stop use and ask a doctor if:
    ■Condition worsens, if symptoms
    persist for more than 7 days or clear up
    and occur again within a few days.
    ■Skin redness or excessive irritation of
    the skin develops.

  • PREGNANCY OR BREAST FEEDING

    ■ If pregnant or breastfeedlng, ask a
    doctor before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out ofthe reach of
    chilaren:
    If swallowed, get medical help or
    contact a Poison Control Center
    immediately

  • DOSAGE & ADMINISTRATION

    Directions:
    ■ Adults and children 12 years of age
    and older: apply to affected area not
    more than 3 to 4 times dally.
    ■ Children under 12 years of age:
    ask a doctor

  • OTHER SAFETY INFORMATION

    Other Information:
    Store in a cool dry place 68 - 77 F
    (20 - 25 C) Minor separation may
    occur. Shake well before using.

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Acrylamide/Sodium Acryloyldimethyl
    Taurate Copolymer, Aloe Barbadensis
    Leaf Juice, Arnica Oil, Behentrimonium
    Methosulfate, Caprylic/Capric
    Triglyceride, Capryly1 Glycol, Cetearyl
    Alcohol, Cetyl Alcohol, Cholecalciferol,
    Chondroitin Sulfate, Coenzyme
    Q 10, Corn Oil, Deionized Water, Emu
    Oil, Glucosamine Sulfate, Glycerin,
    Green (Camellia Sinensis) Tea Extract,
    Isohexadecane, Peppermint Oil*,
    Phenoxyethanol, Polysorbate 80, SO
    Alcohol, Shark cartilage, Shea Butter,
    Sorbic Acid, Tetrahexyldecyl
    Ascorbate, Tocopheryl Acetate,
    Yucca (Glauca) Root Extract.
    *A source of natural menthol.

  • QUESTIONS

    Ouestlons?
    Call 1-855-223-6010
    Weekdays between 9am to 5pm CST

  • PACKAGE LABELING - PRINCIPAL DISPLAY PANEL

    SOOTHE & MOVE
    PAIN RELIEF CREAM

    soothing relief that keeps you moving

    Doctor Formulated & Recommended

    • Fast Acting Topical
    • Deep Penetrating
    • No Greasy Residue

    ALL33
    Net Wt. 2.75 Oz
    (77.96 g)
    Vitamin C, D, E • Botanicals • Antioxidants

    Shake before use

    Ouestlons?
    call 1-855-223-6010
    Weekdays betwean 9am to 5pm CST
    Distributed by Simtec, LLC.
    Beverly Hills, CA

    Soothe&Move

    RES

  • INGREDIENTS AND APPEARANCE
    SOOTHE AND MOVE PAIN RELIEF CREAM 
    camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78805-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.18 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    CORN OIL (UNII: 8470G57WFM)  
    WATER (UNII: 059QF0KO0R)  
    EMU OIL (UNII: 344821WD61)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    SHARK CARTILAGE (UNII: D2YCN1I522)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SORBIC ACID (UNII: X045WJ989B)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78805-005-0177.96 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/12/2020
    Labeler - Simtec LLC (117251669)
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