AMERICAN SAFETY FIRST AID- lidocaine hcl spray

American Safety First Aid by

Drug Labeling and Warnings

American Safety First Aid by is a Otc medication manufactured, distributed, or labeled by Orazen Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCL 2%

Purpose

External analgesic

Uses

for the temporary relief of pain associated with minor burns

Warnings

For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas

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.

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

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

Questions?

1-866-651-3660
Mon-Fri 8:00am-5:00pm EST

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

AMERICAN SAFETY FIRST AID 
lidocaine hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71927-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
TEA TREE OIL (UNII: VIF565UC2G)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71927-012-01	59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/03/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/03/2022

Labeler - Orazen Inc (080916640)