Active Ingredient:
Lidocaine 4% w/w
Lidocaine Cream
FDA Label NDC 42291-399
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avkare for the product Lidocaine (NDC 42291-399). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient:, purpose, uses, warnings, when using this product, stop use and ask doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Package Label.Principal Display Panel
NDC 42291-399-30
Lidocaine
4%
Cream
Topical Anesthetic Cream
Net Wt. 30 gm
Drug Facts
Active ingredient Purpose
Lidocaine 4% 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
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