Helocaine Cold Sore Fever Blister Treatment

Helocaine Cold Sore Fever Blister Treatment
SPL v2
SPL
SPL Set ID 1b2eae09-5de0-9219-e063-6294a90af046
Route
TOPICAL
Published
Effective Date 2024-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetracaine (20 mg) Mineral Oil (744 mg)
Inactive Ingredients
High Density Polyethylene Carboxymethylcellulose Sodium, Unspecified Form Polyethylene Glycol, Unspecified Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01
Description

Tetracaine 2% Mineral oil 74.4%

Purpose

Topical analgesic Skin protectant

Medication Information

Purpose

Topical analgesic

Skin protectant

Description

Tetracaine 2% Mineral oil 74.4%

Uses
  • for the temporary relief of pain and itching associated with fever blisters and cold sores
  • helps prevent and temporarily protects chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
Warnings

For external use only.

Directions

Adults and children 2 years of age and older

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

Children under the age of 2

  • consult a doctor
Do Not Use
  • on • deep or puncture wounds • animal bites • serious burns
  • in large quantities, particularly over raw surfaces or blistered areas
Package Labeling

Other Information
  • store at 20º - 25º C (68º - 77º F)
Active Ingredients

Tetracaine 2%

Mineral oil 74.4%

Inactive Ingredients

peppermint oil, polyethylene, polyethylene oxide, polyethylene glycol, sodium carboxymethylcellulose

Questions Or Comments?

call 1- (877) 513-3057 (toll-free)

When Using This Product
  • do not get into eyes
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • allergic reaction (blister or rash worsens) to any of the ingredients
Keep Out of Reach of Children.

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

Structured Label Content

Uses
  • for the temporary relief of pain and itching associated with fever blisters and cold sores
  • helps prevent and temporarily protects chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
Purpose

Topical analgesic

Skin protectant

Warnings

For external use only.

Directions

Adults and children 2 years of age and older

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

Children under the age of 2

  • consult a doctor
Do Not Use (Do not use)
  • on • deep or puncture wounds • animal bites • serious burns
  • in large quantities, particularly over raw surfaces or blistered areas
Package Labeling (Package labeling)

Other Information (Other information)
  • store at 20º - 25º C (68º - 77º F)
Active Ingredients (Active ingredients)

Tetracaine 2%

Mineral oil 74.4%

Inactive Ingredients (Inactive ingredients)

peppermint oil, polyethylene, polyethylene oxide, polyethylene glycol, sodium carboxymethylcellulose

Questions Or Comments? (Questions or comments?)

call 1- (877) 513-3057 (toll-free)

When Using This Product (When using this product)
  • do not get into eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • allergic reaction (blister or rash worsens) to any of the ingredients
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:13.700948 · Updated: 2026-03-14T23:12:24.385926