THERACARE 4% LIDOCAINE AND 1% MENTHOL CREAM- menthol and lidocaine 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:

Veridian Healthcare

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Lidocaine HCl 4%............................................................................................................................Topical anesthetic Menthol 1%.......................................................................................................................................Topical analgesic temporarily relieves minor pain

Authorization status:

OTC monograph not final

Summary of Product characteristics

THERACARE 4% LIDOCAINE AND 1% MENTHOL CREAM- MENTHOL AND
LIDOCAINE CREAM
VERIDIAN HEALTHCARE
_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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THERACARE 4% LIDOCAINE & 1% MENTHOL CREAM
ACTIVE INGREDIENTS
Lidocaine HCL
Menthol
PURPOSES
Lidocaine HCl
4%............................................................................................................................Topical
anesthetic
Menthol
1%.......................................................................................................................................Topical
analgesic
USE
temporarily relieves minor pain
WARNINGS
For external use only. Avoid contact with eyes
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
WHEN USING THIS PRODUCT
■ use only as directed. Read and follow all directions and warnings
on this carton.
■ do not allow contact with the eyes
■ do not bandage or apply local heat (such as heating pads) to the
area of use
STOP USE AND ASK A DOCTOR IF
■ condition worsens
■ symptoms persist for more than 7 days or clear up and occur again
within a few days
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
(800-222-1222) right
away.
DIRECTIONS
ADULTS AND CHILDREN OVER 12 YEARS:
■ apply a thin layer to affected area, not more than 6 to 8 hours,
not exceed 3
applications in a 24 hour period.
CHILDREN 12 YEARS OR YOUNGER: ask a doctor
INACTIVE INGREDIENTS
Alcohol, Aloe Vera Leaf, Aminomethylpropanol, Carbomer Interpolymer
Type A,
Cyclopentasiloxane 5, Dihexadecyl phosphate, Dimethicone,
Dimethicone/Vinyl
Dimethicone Crosspolymer, edetate disodium, Ethylhexylglycerin,
Glyceryl
monostearate, Hydroxyethyl Acrylate/ Sodium Acryloyldimeth