Label: NEWBURY BLUE PAIN BALM- camphor, menthol, methyl salicylate ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 30, 2024

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  • ACTIVE INGREDIENTS

    Camphor 3%

    Menthol 10%

    Methyl Salicylate 25%

  • PURPOSE

    TOPICAL ANESTHETIC

  • USES

    FOR RELIEF FROM ACHES, ARTHRITIS, MUSCLE SPASMS, AND OVERALL NECK AND BACK PAIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

  • 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.

  • STOP USE AND ASK A DOCTOR IF:

    • AN ALLERGIC REACTION OCCURS
    • REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS BEGIN.
    • THE CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS
  • OTHER INFORMATION

    STORE BETWEEN 15-30°C (59-86°F). AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40°C (104°F).

  • DIRECTIONS

    APPLY BALM LIBERALLY AND GENTLY MASSAGE THE AFFECTED AREA. MASSAGE UNTIL ABSORBED INTO SKIN. WASH HANDS WITH WATER AND SOAP AFTER APPLICATION AND AVOID CONTACT WITH EYES. CHILDREN UNDER 18 YEARS OF AGE SHOULD CONSULT A PHYSICIAN BEFORE USE.

  • INACTIVE INGREDIENTS

    ALOE BARBADENSIS FLOWER EXTRACT, AMPELOPSIS JAPONICA ROOT EXTRACT, ANGELICA POLYMORPHA SINENSIS ROOT EXTRACT, ANGELICA PUBESCENS ROOT EXTRACT, BEESWAX (CERA ALBA), BOSWELLIA CARTERII RESIN EXTRACT, CAMPHOR, CANOLA OIL, CINNAMOMUM CASSIA BARK EXTRACT, COCCINIA INDICA (IVY GOURD) FRUIT EXTRACT, CORALLINA OFFICINALIS (SEAWEED) EXTRACT, CURCUMA LONGA ROOT EXTRACT, EUCALYPTUS GLOBULUS LEAF OIL, EUPHORBIA CERIFERA (CANDELILLA WAX) CERA, GLYCYRRHIZA URALENSIS ROOT EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, MELIA AZADIRACHTA FLOWER EXTRACT, MELIA AZADIRACHTA LEAF EXTRACT, MENTHA PIPERITA (PEPPERMINT) OIL, MENTHOL, METHYL SALICYLATE, OCIMUM BASILICUM (BASIL) FLOWER/LEAF EXTRACT, OCIMUM SANCTUM (TULSI) LEAF EXTRACT, OLYHYDROXYSTEARIC ACID, REHMANNIA GLUTINOSA ROOT EXTRACT, RICINUS COMMUNIS (CASTOR) SEED OIL, SCROPHULARIA NODOSA EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SOLANUM MELONGENA (EGGPLANT) FRUIT EXTRACT, TOCOPHERYL ACETATE

  • PRINCIPAL DISPLAY PANEL

    UC

  • INGREDIENTS AND APPEARANCE
    NEWBURY BLUE PAIN BALM 
    camphor, menthol, methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83501-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE25 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CINNAMOMUM CASSIA WHOLE (UNII: 9BPF21T8ZR)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    SOLANUM MELONGENA WHOLE (UNII: 5DS5EE0N93)  
    OCIMUM BASILICUM WHOLE (UNII: P4815JL4O3)  
    HOLY BASIL LEAF (UNII: SCJ765569P)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    COCCINIA GRANDIS WHOLE (UNII: S4R7X48WED)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)  
    AMPELOPSIS JAPONICA ROOT (UNII: O2672197TF)  
    ANGELICA POLYMORPHA ROOT (UNII: HZ12173363)  
    CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83501-101-1130 mL in 1 JAR; Type 0: Not a Combination Product08/03/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/03/2024
    Labeler - Newbury Extracts, LLC (119006747)
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