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Package Insert and Label Information: Panitrol XR

By Enzyme Labs | Last revised: 1 January 2011

PANITROL XR- menthol cream
Enzyme Labs

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.

Menthol 5%

Topical analgesic

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

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

For external use only.

Do not use

  • on wounds or damaged skin
  • with a heating pad

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 this product

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

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

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

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

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

store in a cool, dry place away from direct sunlight

Call 1-877-500-5529

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

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
Panitrol Label
(click image for full-size original)
PANITROL XR menthol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59940-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 4.25 g in 85 g
Inactive Ingredients
Ingredient Name Strength
ALOE
AVOCADO OIL
CYCLOMETHICONE
GRAPE SEED OIL
METHYL SALICYLATE
PHENOXYETHANOL
METHYLPARABEN
SHEA BUTTER
STEARETH-2
STEARETH-10
STEARIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59940-001-03 85 g in 1 TUBE None
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 Operations
Accupack Midwest Inc. 139637433 manufacture

Revised: 01/2011 Enzyme Labs