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

Description

Benzalkonium Cl 0.13%  LidocaineHCI 4%

Purpose

First aid antiseptic  Pain relieving 


Medication Information

Purpose

First aid antiseptic 

Pain relieving 

Description

Benzalkonium Cl 0.13%  LidocaineHCI 4%

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

Label

Warnings

For external use only

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

Other Information

Avoid excessive heat

Active Ingredients 

Benzalkonium Cl 0.13% 

LidocaineHCI 4%

Inactive Ingredients

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

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

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

Label

Purpose

First aid antiseptic 

Pain relieving 

Warnings

For external use only

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

Other Information (Other information)

Avoid excessive heat

Active Ingredients  (Active ingredients )

Benzalkonium Cl 0.13% 

LidocaineHCI 4%

Inactive Ingredients

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

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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