LIDOCAINE HYDROCHLORIDE gel

Lidocaine Hydrochloride by

Drug Labeling and Warnings

Lidocaine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Provision Medical, Safetec of America, Inc.. 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 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 contact a Poison Control Center right away.

Directions

• clean affected area
• apply small amount not more than 3 times daily
• children under 2: consult a doctor

Inactive Ingredients

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Principal Display Panel – 0.9 g Packet Label

First Aid Burn Cream

The Provision
First Aid
Line™

For Burns
and Cuts

0.9 g (1/32 oz.)

INGREDIENTS AND APPEARANCE

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69103-5000
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 g

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
propylene glycol (UNII: 6DC9Q167V3)
diazolidinyl urea (UNII: H5RIZ3MPW4)
water (UNII: 059QF0KO0R)
menthol (UNII: L7T10EIP3A)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
trolamine (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69103-5000-0	0.9 g in 1 PACKET; Type 0: Not a Combination Product	07/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/25/2022

Labeler - Provision Medical (036936831)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(69103-5000)