Valerin Tablet
FDA Label NDC 99528-606

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wonder Laboratories for the product Valerin (NDC 99528-606). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - ask doctor, indications & usage, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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