KOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]

KOOL COMFORT PAIN RELIEVING ROLL-ON (MENTHOL) LOTION [WONDER LABORATORIES]
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NDC 99528-3590-3
Set ID 78d151c5-b7b1-424f-9fea-5c562de1e147
Category HUMAN OTC DRUG LABEL
Packager Wonder Laboratories
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    EACH TABLET CONTAINS:
    6 parts Valerian Root (Quad-Strength) 1X, 3 parts Passiflora (Quad-Strength) 1X, 1 part Magnesium Carbonate 1X.

  • PURPOSE

    For Relief of Muscle Spasms
    Tension and Stress

  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental overdose seek professional assistance or contact a poison control center immediately.

  • INDICATIONS & USAGE

    INDICATIONS: For temporary relief of muscle spasms, tension and stress.

  • WARNINGS

    Warning: Do not give to children under twelve except under the advice and supervision of a doctor. If you are pregnant or nursing a baby seek the advice of a health professional before using this product. Do not exceed recommended dosage. Consult a doctor if symptoms are more than mild or if they persist.

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 or more years of age.

    Muscle Spasms - Take 1 or 2 tablets every 3 hours, until relief is obtained. To help prevent recurrence of muscle spasms, continue to take 1 or 2 tablets every 4 hours as needed.

    Tension and Stress - Take 1 or 2 tablets every 4 hours, preferably with meals and at bedtime. To help prevent tension and stress take 1 or 2 tablets every 4 hours as needed.

    Dosage should not exceed 12 tablets in any 24 hour period.

  • INACTIVE INGREDIENT

    Lactose Monohydrate, Maltodextrin, Sodium Starch Glycolate Type A Potato, Stearic Acid, Silica

  • PRINCIPAL DISPLAY PANEL

    Valerin Label

  • INGREDIENTS AND APPEARANCE
    VALERIN 
    valerian root, passiflora, magnesium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:99528-606
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER3 [hp_X]
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorbrown (brown with dark brown speckles) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 36
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:99528-606-9090 in 1 BOTTLE; Type 0: Not a Combination Product06/12/1986
    2NDC:99528-606-4545 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2019
    3NDC:99528-606-25250 in 1 BOTTLE; Type 0: Not a Combination Product06/12/1986
    4NDC:99528-606-1212 in 1 BAG; Type 0: Not a Combination Product06/01/2017
    5NDC:99528-606-066 in 1 BAG; Type 0: Not a Combination Product06/12/1986
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/12/1986
    Labeler - Wonder Laboratories (078294223)

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