thera plus pain relief cleansing spray

thera plus pain relief cleansing spray
SPL v2
SPL
SPL Set ID 513a620e-f69a-488d-8abc-36e2efccdc13
Route
topical
Published
Effective Date 2025-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
edetate disodium melaleuca alternifolia leaf octoxynol-9 propylene glycol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-03

Purpose

First aid antiseptic Topical analgesic

Description

Benzalkonium chloride 0.13% Lidocaine HCL 4%


Medication Information

Warnings

For external use only.

Uses

for first aid to help prevent bacterial contamination or skin infection and for temporary relief of pain and itching associated with

  • mionr cuts
  • scrapes
  • minor burns
  • sunburn
  • minor skin irritations
Purpose

First aid antiseptic

Topical analgesic

Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • spray a small amount of this product to affected area 1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged, let dry first
  • children under 2 years of age: do not use, ask a doctor before use
Other Information
  • store at room temperature 59º - 77º F (15º- 25º C).
Inactive Ingredients

disodium EDTA, melaleuca alternifolia (tea tree) oil, octoxynol-9, propylene glycol, water

Description

Benzalkonium chloride 0.13% Lidocaine HCL 4%

Drug Facts

Package Labeling:

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine HCL 4%

Questions Or Comments?

1-800-639-3803

Weekdays 9 AM to 4 PM EST

When Using This Product
  • do not use in or near the eyes
  • do not apply over large areas of the body or in large quantities
  • do not apply over raw surfaces or blistered areas
  • do not use longer than 1 week unless directed by a doctor
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Stop Use and Ask A Doctor If 

condition worsens, or symptoms persists for more than 7 days or clear up and then occur again within a few days.

Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites 
  • serious burns

Structured Label Content

Warnings

For external use only.

Uses

for first aid to help prevent bacterial contamination or skin infection and for temporary relief of pain and itching associated with

  • mionr cuts
  • scrapes
  • minor burns
  • sunburn
  • minor skin irritations
Purpose

First aid antiseptic

Topical analgesic

Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • spray a small amount of this product to affected area 1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged, let dry first
  • children under 2 years of age: do not use, ask a doctor before use
Other Information (Other information)
  • store at room temperature 59º - 77º F (15º- 25º C).
Inactive Ingredients (Inactive ingredients)

disodium EDTA, melaleuca alternifolia (tea tree) oil, octoxynol-9, propylene glycol, water

Drug Facts

Package Labeling:

Active Ingredients (Active ingredients)

Benzalkonium chloride 0.13%

Lidocaine HCL 4%

Questions Or Comments? (Questions or comments?)

1-800-639-3803

Weekdays 9 AM to 4 PM EST

When Using This Product (When using this product)
  • do not use in or near the eyes
  • do not apply over large areas of the body or in large quantities
  • do not apply over raw surfaces or blistered areas
  • do not use longer than 1 week unless directed by a doctor
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 (1-800-222-1222).

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )

condition worsens, or symptoms persists for more than 7 days or clear up and then occur again within a few days.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites 
  • serious burns

Advanced Ingredient Data


Raw Label Data

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