drug facts

drug facts
SPL v3
SPL
SPL Set ID 1adb9b74-4a01-4461-b845-f3aedcb3f810
Route
topical
Published
Effective Date 2023-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzyl alcohol (40 mg)
Inactive Ingredients
carbomer copolymer type b (allyl pentaerythritol crosslinked) aloe vera leaf aminomethylpropanol cetostearyl alcohol ceteth-20 phosphate dihexadecyl phosphate citric acid monohydrate water dimethicone hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) squalene polysorbate 60 propylene glycol alcohol steareth-21

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2021-04-23 Until 2027-12-31
Purpose

Topical anesthetic Topical anesthetic

Description

Benzyl alcohol 10% Lidocaine HCl 4%

Medication Information

Warnings

For external use only

Purpose

Topical anesthetic

Topical anesthetic

Directions
  • Adults and children 12 years of age and over:
  • clean and dry affected area
  • apply 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

Acrylates/C10-30 Acrylate Crosspolymer, Aloe Vera Gel 10 X, Aminomethyl Propanol, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Citric Acid, Deionized Water, Dimethicone, Hydroxyethyl Acrlyate/Sodium, Acryloyldimethyl Taurate Copolymer, Squalane, Polysorbate 60, Propylene Gylcol, SDA 40-B Alcohol, Steareth-21.

Description

Benzyl alcohol 10% Lidocaine HCl 4%

Use

For the temporary relief of pain

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 Ingredients

Benzyl alcohol 10%

Lidocaine HCl 4%

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 If
  • 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 and Pets.

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

Principal Display Panel – 85 G Carton Label

CVS

Health™

Compare to the

active ingredients in

Salonpas ®Lidocaine

PLUS Cream*

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription ✝

Lidocaine

Plus

PAIN RELIEVING CREAM

LIDOCAINE HCl 4%

BENZYL ALCOHOL 10%

Topical anesthetics

Non-greasy

  • Fast acting
  • Numbing relief
  • Unscented

Non-greasy

cream

Package Contains

One Tube

✝Among over the counter

topical analgesics.

NET WT 3 0Z (85 g)

Structured Label Content

Warnings

For external use only

Purpose

Topical anesthetic

Topical anesthetic

Directions
  • Adults and children 12 years of age and over:
  • clean and dry affected area
  • apply 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)

Acrylates/C10-30 Acrylate Crosspolymer, Aloe Vera Gel 10 X, Aminomethyl Propanol, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Citric Acid, Deionized Water, Dimethicone, Hydroxyethyl Acrlyate/Sodium, Acryloyldimethyl Taurate Copolymer, Squalane, Polysorbate 60, Propylene Gylcol, SDA 40-B Alcohol, Steareth-21.

Use

For the temporary relief of pain

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 Ingredients (Active ingredients)

Benzyl alcohol 10%

Lidocaine HCl 4%

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 If (Stop use and ask a doctor if)
  • 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 and Pets. (Keep out of reach of children and pets.)

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

Principal Display Panel – 85 G Carton Label (Principal-Display Panel – 85 g Carton Label)

CVS

Health™

Compare to the

active ingredients in

Salonpas ®Lidocaine

PLUS Cream*

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription ✝

Lidocaine

Plus

PAIN RELIEVING CREAM

LIDOCAINE HCl 4%

BENZYL ALCOHOL 10%

Topical anesthetics

Non-greasy

  • Fast acting
  • Numbing relief
  • Unscented

Non-greasy

cream

Package Contains

One Tube

✝Among over the counter

topical analgesics.

NET WT 3 0Z (85 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:39.350826 · Updated: 2026-03-14T23:03:50.462651