71927-012 American Safety & First Aid Burn Spray

71927-012 American Safety & First Aid Burn Spray
SPL v2
SPL
SPL Set ID ea2f776b-dfd0-6ce4-e053-2995a90af009
Route
TOPICAL
Published
Effective Date 2022-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Hypromelloses Water Glycerin Octoxynol 9 Tea Tree Oil Polyoxyl 40 Hydrogenated Castor Oil Phenoxyethanol Propylene Glycol Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-03

Description

Lidocaine HCL 2%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Lidocaine HCL 2%

Uses

for the temporary relief of pain associated with minor burns

Warnings

For external use only

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: consult a doctor
Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

Questions?

1-866-651-3660

Mon-Fri 8:00am-5:00pm EST

Active Ingredient

Lidocaine HCL 2%

Other Information
  • store at room temperature
  • you may report a serious adverse reaction to this product to 1-866-651-3660
Inactive Ingredients

glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist more than 7 days
  • condition clears up and occurs again within a few days
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel


Structured Label Content

Uses

for the temporary relief of pain associated with minor burns

Purpose

External analgesic

Warnings

For external use only

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: consult a doctor
Do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas

Questions?

1-866-651-3660

Mon-Fri 8:00am-5:00pm EST

Active Ingredient (Active ingredient)

Lidocaine HCL 2%

Other Information (Other information)
  • store at room temperature
  • you may report a serious adverse reaction to this product to 1-866-651-3660
Inactive Ingredients (Inactive ingredients)

glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist more than 7 days
  • condition clears up and occurs again within a few days
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.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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