Label: BAKERS BEST ARTHRITIS PAIN RELIEF - methyl salicylate, menthol and lidocaine hydrochloride cream
- NDC Code(s): 76102-100-02
- Packager: Baker's Best
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active Ingredients: Methyl Salicylate (4.50%), Menthol (2.50%), Lidocaine HCl (1.00%).Close
Purpose: Pain Relief
- INACTIVE INGREDIENT
Inactive Ingredients: Deionized Water, Aloe Vera Gel, Cetyl Alcohol, PEG-8, Isopropyl Myristate, Emu Oil, MSM, Glucosamine Sulfate, Polyacrylamide, C13-14 Isoparaffin, Laurenth-7, Propylene Glycol, Methyl Paraben, Propyl Paraben, Diazolidinyl Urea, Acrylates/C10-13 Alkyl Acrylate, Triethanolamine, Polysorbate-80.Close
- INDICATIONS & USAGE
Uses: For temporary relief of minor aches and pains of muscles and joints associated with arthritis, sprains, and simple backaches.Close
- For external use only.
- Avoid contact with eyes, mucous membranes and broken or irritated skin.
- In case of accidental contact, flush with water.
- KEEP OUT OF REACH OF CHILDREN
Keep out of the reach of children.
- WHEN USING
- If irritation occurs, discontinue use immediately.
- Do not tightly wrap or bandage or use with other topical preparations or heating pads.
- ASK DOCTOR
- Consult a doctor if you are pregnant/nursing, under 12 years old, have sensitive skin, your condition persists or worsens, or excessive burning or irritation persists.
- DOSAGE & ADMINISTRATION
Directions: Adults and children 12 years of age and over, apply product directly to affected areas and gently rub until it's fully absorbed. Product may be used as necessary, but should not be used more than 3-4 times daily.Close
- SPL UNCLASSIFIED SECTION
- Use only as directed
- Store at room temperature
Distributed by: Baker's Best Health Products, Inc.
P.O. Box 2099, Wixom, MI 48393
- PRINCIPAL DISPLAY PANEL
Arthritis Pain Relief Cream
Net Wt. 2oz (56.7g)
To reorder, call 1-800-720-0099 or visit www.bakersbesthealth.com
- INGREDIENTS AND APPEARANCE
BAKERS BEST ARTHRITIS PAIN RELIEF
methyl salicylate, menthol, lidocaine hydrochloride cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76102-100 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE 4.5 g in 100 g MENTHOL (MENTHOL) MENTHOL 2.5 g in 100 g LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER ALOE VERA LEAF CETYL ALCOHOL POLYETHYLENE GLYCOL 400 ISOPROPYL MYRISTATE EMU OIL DIMETHYL SULFONE GLUCOSAMINE SULFATE C13-14 ISOPARAFFIN LAURETH-7 PROPYLENE GLYCOL METHYLPARABEN PROPYLPARABEN DIAZOLIDINYL UREA TROLAMINE POLYSORBATE 80 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76102-100-02 56.7 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/10/2011 Labeler - Baker's Best (967388476)