HOT AND COLD CREAM WITH LIDOCAINE PAIN RELIEVING- lidocaine hcl and 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:

Velocity Pharma LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Lidocaine- Topical anesthetic, Menthol- Topical Analgesic Temporarily relieves minor pain

Authorization status:

OTC monograph not final

Summary of Product characteristics

HOT AND COLD CREAM WITH LIDOCAINE PAIN RELIEVING- LIDOCAINE HCL AND
MENTHOL CREAM
VELOCITY PHARMA 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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HOT AND COLD PAIN RELIEVING CREAM WITH LIDOCAINE: FAMILY WELLNESS
DRUG FACTS
_HOT AND COLD CREAM WITH LIDOCAINE- FAMILY WELLNESS_
_PAIN RELIEVING CREAM_
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Lidocaine HCl 4%
Menthol 1%
_PURPOSES_
Lidocaine- Topical anesthetic,
Menthol- Topical Analgesic
US ES
Temporarily relieves minor pain
_WARNINGS_
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 tightly or apply local heat (such as heating pads) to
the area of use or use with a
medicated patch
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.
_DIRECTIONS_
ADULTS AND CHILDREN OVER 12 YEARS:
apply a thin layer to affected area every 6 to 8 hours, not to exceed
3 applications in a 24 hour
period
AFTER APPLYING, WASH HANDS WITH SOAP AND WATER
CHILDREN 12 YEARS OR YOUNGER: ASK A DOCTOR
_INACTIVE INGREDIENTS_
Butylated hydroxyl toluene,cetostearyl alcohol,cetomacrogol 100