UNISHIELD FIRST AID BURN- lidocaine hcl spray

UniShield First Aid Burn by

Drug Labeling and Warnings

UniShield First Aid Burn by is a Otc medication manufactured, distributed, or labeled by Unishield. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCL 2.0%

Purpose

.Topical pain relief

Uses

Temporary pain relief associated with minor burns

Warnings

For external use only

Do not use

• in large quantities, particularly over raw or blistered areas.
• near eyes, if this happens rinse thoroughly with water

Stop use and ask a doctor

if condition worsens or persists for more than 7 days or clears up and returns.

Keep out of reach of children.

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

Directions

• spray an over layer of burn spray over cleaned affected area not more than 3-4 times daily
• not to be used on children under 12 years of age

Inactive ingredients

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

Questions or comments？

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Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

UNISHIELD FIRST AID BURN 
lidocaine hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-0002
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)
TEA TREE OIL (UNII: VIF565UC2G)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49314-0002-1	59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/20/2023

Labeler - Unishield (790677053)

Registrant - Nantong Health & Beyond Hygienic Products Inc. (421280161)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(49314-0002)