Lidocaine Pain Relieving Creme- Careone

Lidocaine Pain Relieving Creme- Careone
SPL v2
SPL
SPL Set ID 48984478-b215-4e37-b37c-47de96263083
Route
TOPICAL
Published
Effective Date 2017-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Butylated Hydroxytoluene Cetostearyl Alcohol Ceteth-2 Cetyl Alcohol Edetate Disodium Sodium Phosphate, Monobasic, Anhydrous Light Mineral Oil Propylene Glycol Sorbic Acid Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-03-03

Description

Drug Facts

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Drug Facts

Uses

temporarily relieves minor pain 

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

children 12 years and 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
Outer Label

ODOR FREE

WITH 4% LIDOCAINE 

Pain Relieving Crème

Net wt 2.7 oz (76.5 g)

192 bottles in a case.

Active Ingredient

Lidocaine HCI 4%

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.

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
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Lidocaine Pain Relieving Creme

Drug Facts


Structured Label Content

Uses

temporarily relieves minor pain 

Purpose

Topical anesthetic

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

children 12 years and 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
Outer Label

ODOR FREE

WITH 4% LIDOCAINE 

Pain Relieving Crème

Net wt 2.7 oz (76.5 g)

192 bottles in a case.

Active Ingredient (Active ingredient)

Lidocaine HCI 4%

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.

When Using This Product (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 (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
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

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

ask a health professional before use.

Lidocaine Pain Relieving Creme

Drug Facts


Advanced Ingredient Data


Raw Label Data

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