FDA.reportPublic FDA data

Zensa - 4% Lidocaine Cream

Manufacturer
Alera Skin Care Products Inc.
Effective date
2026-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-18 05:11:32

Label at a glance#

ProductZensa
Active ingredientLIDOCAINE
Label structure13 sections

Indications and uses

temporarily relieves pain and itching due to: minor cuts minor scrapes sunburn minor skin irritations minor burns insect bites

Dosage and administration

Adults and children 2 years and older: Apply externally to the affected area not more than 3-4 times daily. Children under 2 years: Do not use. Consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to:

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

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw surfaces or blistered areas
  • over large areas of the body.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • allergic reaction occurs
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl alcohol, carbomer homopolymer, lecithin, dl-alpha-tocopheryl acetate, propylene glycol, water

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and older: Apply externally to the affected area not more than 3-4 times daily.
  • Children under 2 years: Do not use. Consult a doctor.

Other information

OTHER SAFETY INFORMATION

  • Store at 15°-30° C (59°-86° F)

Questions?

OTC - QUESTIONS SECTION

1-844-441-7546

PRINCIPAL DISPLAY PANEL - 100 g (3.5 oz) Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

zensa
LIDOCAINE CREAM

WITH 4% LIDOCAINE

alera SKINCARE

NDC 69805-788-01
100g (3.5 oz)

Carton LabelCarton Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130628235620185GTIN-13: 0628235620185
EAN-13: 0628235620185
GTIN-12: 628235620185
UPC-A: 628235620185
GTIN storage (14 digits): 00628235620185		zensa-carton-v1.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69805-78869805-788-02, 69805-788-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
LIDOCAINE98PI200987ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZensaLIDOCAINEAlera Skin Care Products Inc.549348ec-2eb2-3781-e063-6294a90a2f4a2026-06-18WarningsExact identifier
ndc (package): 69805-788-01
ndc (package): 69805-788-02
ndc (product): 69805-788
ndc11 (package): 69805078801
ndc11 (package): 69805078802
spl id: 549348ec-2eb3-3781-e063-6294a90a2f4a
spl set id: 549348ec-2eb2-3781-e063-6294a90a2f4a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.