LIDOCAINE HCL 4% MENTHOL 1% ointment

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:

OPMX LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

temporary relieves minor pain Topical anesthetic Topical analgesic

Authorization status:

OTC monograph not final

Summary of Product characteristics

LIDOCAINE HCL 4% MENTHOL 1%- LIDOCAINE HCL 4% MENTHOL 1% OINTMENT
OPMX LLC
_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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CALMADRAZOS
LIDOCAINE HCL 4% AND MENTHOL 1%
Lidocaine HCl 4%
Menthol 1%
benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80,
propylene glycol,
purified water triethanolamine, vitamin E
Adults and children 12 years and older: apply a thin layer to affected
area every 6 to 8
hours, not to exceed 3 to 4 applications in a 24-hour period.
BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.
Children under 12 years: ask a doctor
temporary relieves minor pain
FOR EXTERNAL USE ONLY
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 label, rare cases of serious burns have been reported
with products of
this type, do not bandage or apply local heat (such as heating pads)
to the area of use
or use with a medicated, avoid contact with eyes and mucous membranes,
a transient
burning sensation may occur upon application but generally disappears
in several days.
STOP USE AND ASK A DOCTOR if condition worsens, redness is present,
irritation
develops, symptoms persist for more than 7 days or clear up and occur
again within a
few days, you experience signs of skin injury, such as pain, swelling,
or blistering where
the product was applied.
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center
right away.
Topical anesthetic
Topical analgesic
NDC: 69729-452-72 Calmadrazos
LIDOCAINE HCL 4% MENTHOL 1%
OPMX LLC
lidocaine hcl 4% menthol 1% ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:6