PANITROL XR- menthol cream

Panitrol by

Drug Labeling and Warnings

Panitrol by is a Otc medication manufactured, distributed, or labeled by Enzyme Labs, Accupack Midwest Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 5%

PURPOSE

Topical analgesic

INDICATIONS & USAGE

For the temporary relief of minor aches and pains associated with:

• arthritis
• simple backache
• strains
• bruises
• sprains
  

INACTIVE INGREDIENT

Aloe, Avocado Oil, Ceteareth-20, Cyclomethicone, Grape Seed Oil, MedFlex Relief Proprietary Herbal Blend, Methyl Glucose Sesquistearate, Natural Oil of Wintergreen, Phenoxyethanol, Methylparaben, Shea Butter, Steareth-2, Steareth-10, Stearic Acid, Water

WARNINGS

For external use only.

DO NOT USE

Do not use

• on wounds or damaged skin
• with a heating pad
  

ASK DOCTOR

Ask a doctor before use if you are

• prone to allergic reactions to salicylates, including aspirin
• using product on a child under 12 years of age
  

WHEN USING

When using this product

• use only as directed
• avoid contact with eyes or mucous membranes
• do not bandage tightly
  

STOP USE

Stop use and ask a doctor if

• condition worsens
• if symptoms persist for more than 7 days or clear up and occur again within a few days
• excessive skin irritation occurs
  

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed get medical help or contact a poison center right away.

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

store in a cool, dry place away from direct sunlight

QUESTIONS

Call 1-877-500-5529

Monday through Friday, 9am-5pm or customerservice@enzymelabs.com

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
  

INGREDIENTS AND APPEARANCE

PANITROL  XR
menthol cream

Product 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