Aspercreme With Lidocaine Pain Relieving Creme

Aspercreme With Lidocaine Pain Relieving Creme
SPL v14
SPL
SPL Set ID d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd
Route
TOPICAL
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Vera Leaf Aminomethylpropanol C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Caprylyl Trisiloxane Cetostearyl Alcohol Ceteth-20 Phosphate Dihexadecyl Phosphate Dimethicone Edetate Disodium Ethylhexylglycerin Glyceryl Monostearate Methylparaben Steareth-21 Water Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s At 1.0%) Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-03-01 Until 2021-01-31

Description

Drug Facts

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Drug Facts

Uses

temporarily relieves minor pain 

Section 42229-5

Drug Facts

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 puncture wounds

  • on large areas of the body or on cut, irritated or swollen skin

  • for more than one week without consulting a doctor
Active Ingredient

Lidocaine HCI 4%

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, methylparaben, steareth-21, water

Principal Display Panel

ODOR FREE

Aspercreme

WITH 4% LIDOCAINE

MAXIMUM STRENGTH

Pain Relieving CREME

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 carton.

  • do not allow contact with the eyes and mucous membranes

  • do not bandage or apply local heat (such as heating pads) to the area of use

  • do not use at the same time as other topical analgesics
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
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.


Structured Label Content

Uses

temporarily relieves minor pain 

Section 42229-5 (42229-5)

Drug Facts

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 puncture wounds

  • on large areas of the body or on cut, irritated or swollen skin

  • for more than one week without consulting a doctor
Active Ingredient (Active ingredient)

Lidocaine HCI 4%

Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, methylparaben, steareth-21, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ODOR FREE

Aspercreme

WITH 4% LIDOCAINE

MAXIMUM STRENGTH

Pain Relieving CREME

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 carton.

  • do not allow contact with the eyes and mucous membranes

  • do not bandage or apply local heat (such as heating pads) to the area of use

  • do not use at the same time as other topical analgesics
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
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.


Advanced Ingredient Data


Raw Label Data

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