THERA PLUS PAIN RELIEF CLEANSING- benzalkonium chloride, lidocaine hydrochloride liquid

Thera Plus Pain Relief Cleansing by

Drug Labeling and Warnings

Thera Plus Pain Relief Cleansing by is a Otc medication manufactured, distributed, or labeled by Fourstar Group USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCL 4%

Purpose

First aid antiseptic

Topical analgesic

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.

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

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites 
• serious burns

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.

Keep out of reach of children.

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

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

Questions or comments?

1-800-639-3803

Weekdays 9 AM to 4 PM EST

Package Labeling:

INGREDIENTS AND APPEARANCE

THERA PLUS PAIN RELIEF CLEANSING 
benzalkonium chloride, lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-150-00	148 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	03/03/2025

Labeler - Fourstar Group USA, Inc. (140099503)