signature select pain relieving spray 5 oz

signature select pain relieving spray 5 oz
SPL v2
SPL
SPL Set ID 3cab1b0c-4ffd-9c01-e063-6294a90ad15d
Route
topical
Published
Effective Date 2025-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
water edetate disodium anhydrous octoxynol 9 melaleuca alternifolia (tea tree) leaf oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-10-01

Purpose

First aid antiseptic  Pain relieving 

Description

Benzalkonium Cl 0.13%  LidocaineHCI 4%


Medication Information

Warnings

For external use only

Uses

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

■ minor burns

■ sunburn

■ minor cuts

■scrapes

■ insect bites

■ minor skin irritations

Purpose

First aid antiseptic 

Pain relieving 

Other Information

Avoid excessive heat

Inactive Ingredients

disodium EDTA, melaleuca alterniflia (tea Tree) leaf oil, octoxynol-9, propylene glycol, water

Description

Benzalkonium Cl 0.13%  LidocaineHCI 4%

Label

Directions 

■Adults and children 2 years and older: Cleananddry affectedarea. Shake well;spray small amount on the area 1 to 3 times daily.

May be covered witha sterilebandage;let dry first.

■ Children under 2 years af age: ask a doctor

Active Ingredients 

Benzalkonium Cl 0.13% 

LidocaineHCI 4%

Questions Or Comments?

Call 1-866-1313

When Using This Product

■ avoid contact w th eyes

■ do not use in large quantities, particularly over raw surfaces or blistered areas

Stop Use and Ask A Doctor If

■ condition worsens

■ symptoms persist for more than 7 days

■symptoms clear up and occur again w thin a few days

Ask A Doctor Before Use If You Have

■deep or puncture wounds

■ animalbites

■ serious burns

Keep Out of Reach of Children and Pets.

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


Structured Label Content

Warnings

For external use only

Uses

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

■ minor burns

■ sunburn

■ minor cuts

■scrapes

■ insect bites

■ minor skin irritations

Purpose

First aid antiseptic 

Pain relieving 

Other Information (Other information)

Avoid excessive heat

Inactive Ingredients

disodium EDTA, melaleuca alterniflia (tea Tree) leaf oil, octoxynol-9, propylene glycol, water

Label

Directions 

■Adults and children 2 years and older: Cleananddry affectedarea. Shake well;spray small amount on the area 1 to 3 times daily.

May be covered witha sterilebandage;let dry first.

■ Children under 2 years af age: ask a doctor

Active Ingredients  (Active ingredients )

Benzalkonium Cl 0.13% 

LidocaineHCI 4%

Questions Or Comments? (Questions or comments?)

Call 1-866-1313

When Using This Product (When using this product)

■ avoid contact w th eyes

■ do not use in large quantities, particularly over raw surfaces or blistered areas

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

■ condition worsens

■ symptoms persist for more than 7 days

■symptoms clear up and occur again w thin a few days

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■deep or puncture wounds

■ animalbites

■ serious burns

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

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


Advanced Ingredient Data


Raw Label Data

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