Label: PANITROL XR- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59940-001-03 - Packager: Enzyme Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 1, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- adults and children 12 years of age and older: apply to affected area no more than 3 to 4 times daily
- children under 12 years of age: consult a physician
- apply generously and massage into affected areas until completely absorbed
- apply before and after sports or exercise to help soothe aching muscles, muscle strain
- repeat as needed up to four times per day
- STORAGE AND HANDLING
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
Penetrating Pain Relief
Temporary Relief of Minor Aches and Pains Associated with Arthritis, Simple Backache, Sprains, Bruises and Strains.
- soothing and medicated analgesic rub for aching joints and muscles
- effective for pre-exercise warm-up
- penetrating pain relief
- with skin moisturizing conditioners aloe, shea butter, avocado, and grape seed oil
- contains Enzyme Labs clinically tested Panitrol herbal formula
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INGREDIENTS AND APPEARANCE
PANITROL XR
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59940-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.25 g in 85 g Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) AVOCADO OIL (UNII: 6VNO72PFC1) CYCLOMETHICONE (UNII: NMQ347994Z) GRAPE SEED OIL (UNII: 930MLC8XGG) METHYL SALICYLATE (UNII: LAV5U5022Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) SHEA BUTTER (UNII: K49155WL9Y) STEARETH-2 (UNII: V56DFE46J5) STEARETH-10 (UNII: FD0913P475) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59940-001-03 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/01/2010 Labeler - Enzyme Labs (617686980) Registrant - Enzyme Labs (617686980) Establishment Name Address ID/FEI Business Operations Accupack Midwest Inc. 139637433 manufacture