Label: WILLOW BALM- topical pain reliever cream

  • Category: HUMAN OTC DRUG LABEL

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 January 15, 2018

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  • Active Ingredients

    Menthol 3% Counterirritant

  • Warnings

    WARNINGS for external use only. Use only as directed. Avoid contact
    with eyes and mucus membranes. Do not cover with bandage. Do not use on open wounds or damaged skin.
    Keep out of reach of Children. Consult physician for children under 12.

  • Uses

    Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness

  • Other Ingredients

    BOTANICALS White Willow Bark, Camphor, Eucalyptus Oil, Lavender Oil, Geranium Oil, Helichrysum Gymnocephalum Oil,
    Spearment Oil OTHER INGREDIENTS water, mineral oil, cetyp alcohol, stearic acid, stearyl alcohol, cetearyl alcohol,
    cetereth, propylene glycol, isopropyl palmtate, almond oil, glycol monostearate, phenoxy ethanol, caprylyl glycol,
    jojoba seed oil

  • Contact information

    For more informatin contact us at: 888-609-4556, or visit www.willowbalm.com Made in the USA I Woke Up Well Distributing, Inc. US Pat. 8765194

  • Warnings

    Keep Out Of Reach of Children

  • Directions

    Apply the product directly to the affected area. Product may be used as necessary, but should not be used more than four times daily.

  • Purpose

    Use for the temporary relief of minor aches and muscle pains.

  • main label

    Main Label

  • INGREDIENTS AND APPEARANCE
    WILLOW BALM 
    topical pain reliever cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71629-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) 0.013 g  in 1 g
    LAVENDER OIL (UNII: ZBP1YXW0H8) 0.013 g  in 1 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.095 g  in 1 g
    WATER (UNII: 059QF0KO0R) 0.072 g  in 1 g
    CETYL ALCOHOL (UNII: 936JST6JCN) 0.0238 g  in 1 g
    HELICHRYSUM GYMNOCEPHALUM WHOLE (UNII: 0369G6I64W) 0.009 g  in 1 g
    STEARIC ACID (UNII: 4ELV7Z65AP) 0.238 g  in 1 g
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 0.119 g  in 1 g
    ALMOND OIL (UNII: 66YXD4DKO9) 0.019 g  in 1 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.013 g  in 1 g
    CETEARETH-10 (UNII: K9YLE2L8PA) 0.476 g  in 1 g
    SALIX ALBA BARK (UNII: 205MXS71H7) 0.049 g  in 1 g
    SPEARMINT (UNII: J7I2T6IV1N) 0.002 g  in 1 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) 0.078 g  in 1 g
    HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) (UNII: AS2SZ9757N) 0.0095 g  in 1 g
    .ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O) 0.078 g  in 1 g
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 0.019 g  in 1 g
    MINERAL OIL (UNII: T5L8T28FGP) 0.571 g  in 1 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71629-035-011 g in 1 TUBE; Type 0: Not a Combination Product01/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/15/2018
    Labeler - I Woke Up Well Distributing Inc (025251119)
    Registrant - I Woke Up Well Distributing Inc (025251119)
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