FIRST SHIELD- benzalkonium chloride, lidocaine hci cream

FIRST SHIELD by

Drug Labeling and Warnings

FIRST SHIELD by is a Otc medication manufactured, distributed, or labeled by Unishield. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

First aid antiseptic

Topical analgesic

Uses

• temporary relief of pain associated with minor burns
• helps protect against harmful bacteria

Warnings

For external use only.

Do not use

• in eyes
• in large quantities
• over raw surfaces or blistered areas, or on deep puncture wounds, animal bites, serious burns
• for more than one week unless directed by a doctor

Keep out of reach of children.

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

Directions

• clean affected area
• apply a small amount not more than 3-4 times daily
• children under 2 years: do not use,consult a doctor

Other Information

• store at room temperature (do not freeze)
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

aloe barbadensis leaf juice, cetearyl alcohol, disodium EDTA,ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, maltodextrin, propylene glycol,purified water, PEG-100 Stearate, phenoxyethanol, stearic acid, triethanolamine

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST SHIELD 
benzalkonium chloride, lidocaine hci cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49314-0003-2	25 in 1 BOX	04/03/2023
1	NDC: 49314-0003-1	0.9 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/03/2023

Labeler - Unishield (790677053)