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  5. Label Information: Valerin

FDA Label for Valerin

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - ASK DOCTOR
    5. INDICATIONS & USAGE
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Valerin Product Label

The following document was submitted to the FDA by the labeler of this product Wonder Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient:                                                                     Purpose

Natural Menthol USP 3.5%....................................................Cooling Pain Relief


Otc - Purpose



Uses:  Temporary relief of minor aches and pains of sore muscles and joints

associated with - arthritis - backache - strains - sprains


Warnings



Warnings:  For external use only

Flammable:  Keep away from excessive heat or open flame


Otc - Ask Doctor



Ask a doctor before use if you have: Sensitive Skin


Indications & Usage



When Using This Product: Avoid contact with eyes or mucous membranes

- Do not apply to wounds or damaged skin - Do not use with other ointments, creams, sprays or liniments - Do not apply to irritated skin or if excessive irritation develops - Do not bandage - Wash hands after use with cool water - Do not use with heating pad or heating devices

Otc - Stop Use



Stop Use And Ask A Doctor If:  Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding:  Ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children:  If accidentally ingested, get medical help or contact a Poison Control Center right away


Dosage & Administration



- Adults and children 2 years of age and older:  Roll on to the affected areas not more than 4 times daily; massage not necessary

- Children under 2 years of age:  Consult a physician


Storage And Handling



Other Information:  Store in a cool dry place with lid tightly closed


Inactive Ingredient



Inactive Ingredients: carbomer, FDC blue #1, FDC yellow #5, , glycerine, herbal extract (ILEX paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol USP, silicon dioxide, triethanolamine USP, water


Package Label.Principal Display Panel




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