Hot And Cold Pain Relieving Cream With Lidocaine- Careone

Hot And Cold Pain Relieving Cream With Lidocaine- Careone
SPL v5
SPL
SPL Set ID 2f70c7fe-c242-4747-b9e8-7600afb5e45d
Route
TOPICAL
Published
Effective Date 2017-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-09-14

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

Uses

Temporarily relieves minor pain

Purposes

Lidocaine- Topical anesthetic,

Menthol- Topical Analgesic

Warnings

For external use only

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

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
Drug Facts

HOT AND COLD CREAM with LIDOCAINE- RA

PAIN RELIEVING CREAM

Drug Facts

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

Inactive Ingredients

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.

Principal Display Panel

Hot and cold Cream -CareOne



Net Wt 2.7 OZ (76.5 g)

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.


Structured Label Content

Uses

Temporarily relieves minor pain

Purposes

Lidocaine- Topical anesthetic,

Menthol- Topical Analgesic

Warnings

For external use only

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

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
Drug Facts

HOT AND COLD CREAM with LIDOCAINE- RA

PAIN RELIEVING CREAM

Drug Facts

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

Inactive Ingredients (Inactive ingredients)

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Hot and cold Cream -CareOne



Net Wt 2.7 OZ (76.5 g)

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children and Pets. (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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