QR PAIN- analgesic cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
MARYHELENE ENTERPRISES INC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Analgesic for the temporary relief of pain. Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Authorization status:
OTC monograph not final
Authorization number:
73180-005-00, 73180-005-01

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

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)

QR PAIN

analgesic cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7318 0 -0 0 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MANNITO L (UNII: 3OWL53L36 A) (MANNITOL - UNII:3OWL53L36 A)

MANNITOL

30 g in 10 0 g

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

1.25 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

PO LYO XYL 2 0 CETO STEARYL ETHER (UNII: YRC528 SWUY)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

O CTYLDO DECANO L (UNII: 46 1N1O6 14Y)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

WATER (UNII: 0 59 QF0 KO0 R)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7318 0 -0 0 5-0 1

1 in 1 BOX

12/0 1/20 19

1

NDC:7318 0 -0 0 5-0 0

5 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

12/0 1/20 19

Labeler -

MARYHELENE ENT ERPRISES INC (203935056)

Registrant -

MARYHELENE ENT ERPRISES INC (203935056)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

EFULFILLMENT SERVICE INC

0 2313230 6

pa c k(7318 0 -0 0 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

MARYHELENE ENTERPRISES INC

20 39 350 56

la be l(7318 0 -0 0 5)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

MARYHELENE ENTERPRISES INC

PROLAB HEALTH & BEAUTY LTD

259 329 733

ma nufa c ture (7318 0 -0 0 5)

Revised: 3/2020

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