QR PAIN- analgesic cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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

Summary of Product characteristics

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._
----------
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 TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:73180-005
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
MARYHELENE ENTERPRISES INC
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A)
MANNITOL
30 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (