Hot And Cold Cream With Lidocaine-ra

Hot And Cold Cream With Lidocaine-ra
SPL v2
SPL
SPL Set ID 1b502467-1bc8-4067-83e6-eb80d27651ee
Route
TOPICAL
Published
Effective Date 2017-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.4 1) Menthol (0.1 1)
Inactive Ingredients
Butylated Hydroxytoluene Cetostearyl Alcohol Ceteth-2 Cetyl Alcohol Ceteth-20 Phosphate Edetate Disodium Light Mineral Oil Propylene Glycol Sorbic Acid Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-05-25

Description

HOT AND COLD CREAM with LIDOCAINE-RA PAIN RELIEVING CREAM Drug Facts

Purpose

Lidocaine- Topical anesthetic, Menthol- Topical Analgesic


Medication Information

Purpose

Lidocaine- Topical anesthetic, Menthol- Topical Analgesic

Description

HOT AND COLD CREAM with LIDOCAINE-RA PAIN RELIEVING CREAM Drug Facts

Purposes

Lidocaine- Topical anesthetic,

Menthol- Topical Analgesic

Warnings

For external use only

Drug Facts

HOT AND COLD CREAM with LIDOCAINE-RA

PAIN RELIEVING CREAM

Drug Facts

Outer Label

Temporarily relieves minor pain

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
Active Ingredients

Lidocaine HCl 4%

Menthol 1%

When Using Section
  • 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
Dosage & Administration 

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 Ingredient Section

Butylated hydroxyl toluene,cetostearyl alcohol,cetomacrogol 1000,cetyl alcohol,disodium EDTA,disodium hydrogen phosphate,light liquid paraffin,propylene glycol,sorbic acid,transquitol P, white petroleum jelly

Keep Carton As It Contains Important Information

Close cap tightly between uses.

If Pregnant Or Breast Feeding,

ask a health professional before use.

 keep Out of Reach of Children Section

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purposes

Lidocaine- Topical anesthetic,

Menthol- Topical Analgesic

Warnings (WARNINGS)

For external use only

Drug Facts

HOT AND COLD CREAM with LIDOCAINE-RA

PAIN RELIEVING CREAM

Drug Facts

Outer Label

Temporarily relieves minor pain

Do Not Use  (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
Active Ingredients

Lidocaine HCl 4%

Menthol 1%

When Using Section (WHEN USING SECTION)
  • 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
Dosage & Administration  (DOSAGE & ADMINISTRATION )

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 Ingredient Section (INACTIVE INGREDIENT SECTION)

Butylated hydroxyl toluene,cetostearyl alcohol,cetomacrogol 1000,cetyl alcohol,disodium EDTA,disodium hydrogen phosphate,light liquid paraffin,propylene glycol,sorbic acid,transquitol P, white petroleum jelly

Keep Carton As It Contains Important Information

Close cap tightly between uses.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

 keep Out of Reach of Children Section ( KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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