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

Description

Benzalkonium chloride 0.13% Lidocaine HCL 4%

Purpose

First aid antiseptic Topical analgesic


Medication Information

Purpose

First aid antiseptic

Topical analgesic

Description

Benzalkonium chloride 0.13% Lidocaine HCL 4%

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
Warnings

For external use only.

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
Drug Facts

Other Information
  • store at room temperature 59º - 77º F (15º- 25º C).
Package Labeling:

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine HCL 4%

Inactive Ingredients

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

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

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

Warnings

For external use only.

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
Drug Facts

Other Information (Other information)
  • store at room temperature 59º - 77º F (15º- 25º C).
Package Labeling:

Active Ingredients (Active ingredients)

Benzalkonium chloride 0.13%

Lidocaine HCL 4%

Inactive Ingredients (Inactive ingredients)

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

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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