MEDI-FIRST- benzalkonium chloride, lidocaine cream

MEDI-FIRST by

Drug Labeling and Warnings

MEDI-FIRST by is a Otc medication manufactured, distributed, or labeled by Orazen Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCI 0.5%

Purpose

First aid antiseptic

Topical analgesic

Uses

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

Warnings

For external use only.

Do not use

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

Stop use and ask a doctor if

• the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

• Adults and children 2 years and over: clean the affected area, apply a small amount not more than 3 to 4 times daily
• Children under 2 years: do not use, consult a doctor

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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?

800-634-7680

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

MEDI-FIRST 
benzalkonium chloride, lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71927-019
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
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71927-019-02	25 in 1 BOX	02/20/2023
1	NDC: 71927-019-01	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	02/20/2023

Labeler - Orazen Inc (080916640)