QR PAIN- analgesic 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.

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QR PAIN CREAM 5g

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

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 5g (NDC 73180-005-00)

QR Cream 5g

QR PAIN 
analgesic cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73180-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A) MANNITOL30 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-100 STEARATE (UNII: YD01N1999R)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73180-005-011 in 1 BOX12/01/2019
1NDC:73180-005-005 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2019
Labeler - MARYHELENE ENTERPRISES INC (203935056)
Registrant - MARYHELENE ENTERPRISES INC (203935056)

Revised: 1/2023
Document Id: f1ed8384-83d7-6f2a-e053-2a95a90ab08f
Set id: 8f8f53e3-fe31-e7b5-e053-2995a90a710d
Version: 8
Effective Time: 20230110
 
MARYHELENE ENTERPRISES INC