Unscented Pain Relieving Cream + Lidocaine

Unscented Pain Relieving Cream + Lidocaine
SPL v4
SPL
SPL Set ID e33e0097-31d6-8083-e053-2a95a90af5d2
Route
TOPICAL
Published
Effective Date 2023-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzyl Alcohol (100 mg)
Inactive Ingredients
Dimethicone Aminomethylpropanol Butylene Glycol Dihexadecyl Phosphate Glyceryl 1-stearate Maltodextrin Cetostearyl Alcohol Ceteth-10 Phosphate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Polysorbate 80 Steareth-21 Dehydrated Alcohol Water Carbomer Interpolymer Type A (55000 Cps) Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-01

Description

Benzyl alcohol 10% Lidocaine HCl 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Benzyl alcohol 10% Lidocaine HCl 4%

Uses

For temporary relief of pain

Package

Warnings

For external use only

Directions

Adults and children over 12 years :

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



Children under 12 years of age:

consult a doctor

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%

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

alcohol 95%, aloe vera leaf, aminomethylpropanol, butylene glycol,carbomer interpolymer type A (allylsucrose crosslinked), ceteth-10

phosphate, cetostearyl alcohol, dihexadecyl phosphate, dimethicone,glyceryl 1-stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (1001.5%), maltodextrin, polysorbate 80, steareth-21, water

Questions Or Comments?

Toll-Free Customer Care

Help Line 1-866-326-1313

Monday–Friday,

8:30 a.m. – 4:30 p.m. CST

When Using This Product
  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor
  • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again 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 (1-800-222-1222) right away.


Structured Label Content

Uses

For temporary relief of pain

Package

Purpose

Topical anesthetic

Warnings

For external use only

Directions

Adults and children over 12 years :

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



Children under 12 years of age:

consult a doctor

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

Benzyl alcohol 10%

Lidocaine HCl 4%

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

alcohol 95%, aloe vera leaf, aminomethylpropanol, butylene glycol,carbomer interpolymer type A (allylsucrose crosslinked), ceteth-10

phosphate, cetostearyl alcohol, dihexadecyl phosphate, dimethicone,glyceryl 1-stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (1001.5%), maltodextrin, polysorbate 80, steareth-21, water

Questions Or Comments? (Questions or comments?)

Toll-Free Customer Care

Help Line 1-866-326-1313

Monday–Friday,

8:30 a.m. – 4:30 p.m. CST

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again 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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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