LIDOCAINE- lidocaine 5% cream

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by AvKARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Lidocaine 5% w/w

Purpose

Topical anesthetic

Uses

temporarily relieves pain and itching due to:

• minor cuts
• minor scrapes
• sunburn
• minor skin irritations
• minor burns
• insect bites

WARNINGS

For external use only.

When using this product

• do not use in or near the eyes
• do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

• Allergic reaction occurs
• condition worsens or does not improve within 7 days
• symptoms clear up and return within a few days
• redness, irritation, swelling, pain or other symptoms begin or increase

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 and older: Apply externally to the affected area up to 3-4 times daily.
• Children under 2 years of age: Consult a doctor.

Other Information

Store at USP controlled room temperature 20-25 degC (68-77 deg.F).

Inactive ingredients

Ceteareth-6, ceteareth-25, cetyl alcohol, methylparaben, paraffin, propylene glycol, propylparaben, purified water, stearyl alcohol, and xanthan gum.

PRINCIPAL DISPLAY PANEL

NDC: 42291-400-30
Lidocaine
5%
Cream
Topical Anesthetic Cream
Net Wt. 30 gm

Drug Facts
Active ingredient Purpose
Lidocaine 5% w/w
............................Topical anesthetic
Uses
Temporarily relieves pain and
itching due to:
❚ minor cuts ❚ minor scrapes
❚ sunburn ❚ minor burns
❚ minor skin irritations
❚ insect bites
Warnings
For external use only.
When using this product
❚ do not use in or near the eyes
❚ do not use in large quantities,
particularly over raw surfaces
or blistered ares
Stop use and ask a doctor if
❚ allergic reaction occurs
❚ condition worsens or does not
improve within 7 days
❚ symptoms clear up and return
within a few days
❚ redness, irritation, swelling, pain
or other symptoms begin or
increase
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
and older: Apply externally to
the affected area up to 3-4 times
daily.
❚ Children under 2 years of age:
Consult a physician
Other Information
❚ Store at USP controlled room
temperature 20°-25°C
(68° - 77°F)
Inactive Ingredients
Ceteareth-6, ceteareth-25, cetyl
alcohol, methylparaben, paraffin,
propylene glycol, propylparaben,
purified water, stearyl alcohol,
xanthan gum.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
AV 03/18 Rev: 03/18

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42291-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETEARETH-6 (UNII: 2RJS3559D3)
CETEARETH-25 (UNII: 8FA93U5T67)
PARAFFIN (UNII: I9O0E3H2ZE)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42291-400-30	1 in 1 CARTON	07/11/2018
1		30 g in 1 TUBE; 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	07/11/2018

Labeler - AvKARE, Inc. (796560394)