healthwise lidocaine plus cream

healthwise lidocaine plus cream
SPL v1
SPL
SPL Set ID 16f26249-b508-2c6e-e063-6394a90a265b
Route
topical
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzyl alcohol (10 g)
Inactive Ingredients
polysorbate 80 water alcohol maltodextrin hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (45000 mpa.s at 1%) dimethicone butylene glycol dihexadecyl phosphate cetostearyl alcohol aloe vera leaf ceteth-10 phosphate steareth-21 aminomethylpropanol carbomer interpolymer type a (55000 cps) glyceryl 1-stearate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-04-01

Purpose

Topical anesthetic

Description

Benzyl alcohol 10% Lidocaine HCl 4%


Medication Information

Warnings

For external use only.

Purpose

Topical anesthetic

Directions

adults and children over 12 years:

  • clean and dry affected area
  • apply a thin layer to affected area not more than 3 to 4 times daily

children 12 years or younger: ask a doctor

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tightly
Inactive Ingredients

Aloe Vera Leaf, Aminomethyl propanol, butylene glycol, Carbomer Interpolymer Type A (allyl sucrose crosslinked), ceteth-10 phosphate, cetostearyl alcohol, dihexadecyl phosphate, dimethicone, glyceryl 1-stearate, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer (100000 mPa.S at 1.5%), maltodextrin, polysorbate 80, SD alcohol, steareth-21, water

Description

Benzyl alcohol 10% Lidocaine HCl 4%

Principal Display Panel

Use

temporarily pain relief

Do Not Use
  • on wounds or damaged skin
  • in large quantities
  • with a heating pad
  • if you are allergic to any ingredients of this product
Active Ingredient

Benzyl alcohol 10%

Lidocaine HCl 4%

When Using This Product
  • use only as directed.
  • avoid contact with eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days within a few days

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.


Structured Label Content

Warnings

For external use only.

Purpose

Topical anesthetic

Directions

adults and children over 12 years:

  • clean and dry affected area
  • apply a thin layer to affected area not more than 3 to 4 times daily

children 12 years or younger: ask a doctor

Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tightly
Inactive Ingredients (Inactive ingredients)

Aloe Vera Leaf, Aminomethyl propanol, butylene glycol, Carbomer Interpolymer Type A (allyl sucrose crosslinked), ceteth-10 phosphate, cetostearyl alcohol, dihexadecyl phosphate, dimethicone, glyceryl 1-stearate, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer (100000 mPa.S at 1.5%), maltodextrin, polysorbate 80, SD alcohol, steareth-21, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

temporarily pain relief

Do Not Use (Do not use)
  • on wounds or damaged skin
  • in large quantities
  • with a heating pad
  • if you are allergic to any ingredients of this product
Active Ingredient (Active ingredient)

Benzyl alcohol 10%

Lidocaine HCl 4%

When Using This Product (When using this product)
  • use only as directed.
  • avoid contact with eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days within a few days

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

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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