QR PAIN: Package Insert and Label Information

QR PAIN- mannitol and menthol cream
MARYHELENE ENTERPRISES INC

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 FACTS

Active Ingredient

Mannitol 30%

Menthol 1.25%

Purpose

Topical Analgesic

Uses

for the temporary relief of pain.

Warnings

For external use only.

When using this product

  • do not bandage tightly
  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not use with heating pads or other heating devices
  • as with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product
  • do not use in large quantities, particularly over raw surfaces or blistered areas.

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.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older , apply to affected area no more than 3-4 times a day. Children under 12 years of age: do not use, contact a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Lecithin, Ethylhexylglycerin, Ceteareth 20, Glyceryl stearate, Octyldodecanol, Phenoxyethanol, Propylene glycol, Isopropyl Palmitate, Caprylic/Capric triglyceride, Dimethicone, Polyethylene glycol 100 stearate, Water, Cetearyl alcohol.

Questions or Comments?

1-833-772-7326 (1 833 QR CREAM) or visit www.qrcream.com

QR PAIN CREAM 75g (NDC 73180-075-00)

QR Cream
(click image for full-size original)

QR PAIN
analgesic cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73180-075
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MANNITOL (MANNITOL) MANNITOL 30 g in 100 g
MENTHOL (MENTHOL) MENTHOL 1.25 g in 100 g
Inactive Ingredients
Ingredient Name Strength
LECITHIN, SOYBEAN
ETHYLHEXYLGLYCERIN
POLYOXYL 20 CETOSTEARYL ETHER
GLYCERYL MONOSTEARATE
OCTYLDODECANOL
PHENOXYETHANOL
PROPYLENE GLYCOL
ISOPROPYL PALMITATE
MEDIUM-CHAIN TRIGLYCERIDES
DIMETHICONE
PEG-100 STEARATE
WATER
CETOSTEARYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73180-075-01 1 TUBE in 1 BOX contains a TUBE (73180-075-00)
1 NDC:73180-075-00 75 g in 1 TUBE This package is contained within the BOX (73180-075-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 08/01/2019
Labeler — MARYHELENE ENTERPRISES INC (203935056)
Registrant — MARYHELENE ENTERPRISES INC (203935056)
Establishment
Name Address ID/FEI Operations
EFULFILLMENT SERVICE INC 023132306 pack (73180-075)
Establishment
Name Address ID/FEI Operations
MARYHELENE ENTERPRISES INC 203935056 label (73180-075)
Establishment
Name Address ID/FEI Operations
PROLAB HEALTH & BEAUTY LTD 259329733 manufacture (73180-075)

Revised: 03/2020 MARYHELENE ENTERPRISES INC

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