CVS HEALTH COLD AND HOT ROLL-ON- lidocaine, menthol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

NATURAL ESSENTIALS, INC.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical anesthetic Topical analgesic temporarily relieves minor pain

Authorization status:

OTC monograph not final

Summary of Product characteristics

CVS HEALTH COLD AND HOT ROLL-ON - LIDOCAINE, MENTHOL CREAM
NATURAL ESSENTIALS, 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 INGREDIENTS
Lidocaine HCl 4%
Menthol 1%
PURPOSE
Topical anesthetic
Topical analgesic
USES
temporarily relieves minor pain
WARNINGS
FOR EXTERNAL USE ONLY
Avoid contact with eyes or mucous membranes
Do not apply to open wounds or damaged skin
Do not bandage or use heating pad
DO NOT USE
on large areas of the body or on cut, irritated or swollen skin
on puncture wounds
for more than one week without consulting a doctor
STOP USE AND ASK A DOCTOR IF
Condition worsens
servere skin irritation occurs
Symptoms persist for more than 7 days or clear up then reoccur again
within a few
days
ASK A DOCTOR BEFORE USE IF YOU
Have sensitive skin
Are pregnant or breastfeeding
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Rub on affected area - repeat 3 to 4 times daily
for adults and children 12 or over
under 12 consult doctor before use
OTHER INFORMATION
This product may cause allergic reaction in some individuals. Test on
small area
before use.
INACTIVE INGREDIENTS
Acrylates/C10-30 Alkyl Crosspolymer, Aloe Vera Gel 10x, Aminomethyl
Propanol,
Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Deionized
Water,
Dimethicone, Caprylyl Methicone, Polysilicone-11, Disodium EDTA,
Ethylhexylglycerin,
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,
Isohexadecane,
Polysorbate 60, Methylparaben, SDA 40-2 Alcohol, Steareth-21
PRINCIPAL DISPLAY PANEL – 73.9 ML CARTON LABEL
CVS
HEALTH
Compare to active
ingredients in IcyHot
Lidocaine Plus Menthol*
MAXIMUM STRENGTH
LIDOCAINE CONCENTRATION
WITHOUT A PRESCRIPTION
LIDOCAINE
PAIN RELIEF
ROLL-ON
PLUS MENTHOL
LIDOCAINE HCL 4%
MENTHOL 1%
SAFE & EFFECTIVE
FAST ACTING & LONG LASTING
DESENS