QR PAIN- analgesic cream

QR PAIN by

Drug Labeling and Warnings

QR PAIN by is a Otc medication manufactured, distributed, or labeled by MARYHELENE ENTERPRISES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 5g (NDC:

73180-005-00)

INGREDIENTS AND APPEARANCE

QR PAIN 
analgesic cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73180-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A)	MANNITOL	30 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73180-005-01	1 in 1 BOX	12/01/2019
1	NDC: 73180-005-00	5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/01/2019

Labeler - MARYHELENE ENTERPRISES INC (203935056)

Registrant - MARYHELENE ENTERPRISES INC (203935056)

Establishment
Name	Address	ID/FEI	Business Operations
EFULFILLMENT SERVICE INC		023132306	pack(73180-005)

Establishment
Name	Address	ID/FEI	Business Operations
MARYHELENE ENTERPRISES INC		203935056	label(73180-005)

Establishment
Name	Address	ID/FEI	Business Operations
PROLAB HEALTH & BEAUTY LTD		259329733	manufacture(73180-005)