Assured

Manufacturer
Anhui NHU Pharmaceutical Co., Ltd.
Effective date
2015-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:29:36

Label at a glance#

ProductAssured
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Storage and handling

Other Information store at room temperature 59 - 86 F (15 - 30 C)

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive Ingredients   aloe barbadensis leaf juice,

benzalkonium chloride, carbomer 940, glycerin, menthol,

polysorbate 80, propylene glycol, sodium hydroxide, water

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine hydroxide 2.5 %

OTC - PURPOSE SECTION

Purpose

Topical analgesic

INDICATIONS & USAGE SECTION

Uses  for temporary relief of pain associated with

-minor burns  -sunburn

-minor cuts or scrapes   - minor skin irritations

WARNINGS SECTION

Warnings

For external use only

Do not use

-in large quantities, particularly over raw surfaces

or blistered areas

When using this product

-avoid contact with eyes

Stop Use and ask a doctor

-if condition worsens, or if symptoms persist for more than

7 days or clear up and then occur again within a few

days, discontinue use of this product and consult

a physician

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children over 2 years of age:

-clean the affected area and gently dry

-apply to the affected area not more than 3 to 4 times daily

children under 2 years of age; consult a physician

STORAGE AND HANDLING SECTION

Other Information

store at room temperature 59 - 86 F (15 - 30 C)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of labelcopy of label

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69571-00269571-002-01, 69571-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
9842b6ca-34f3-e6f1-e053-2995a90a0bacba97c4ee-e097-4e9d-937a-f5ee4f9d6dfb2019-11-26WarningsExact identifier
spl set id: ba97c4ee-e097-4e9d-937a-f5ee4f9d6dfb

Reported adverse events (FAERS/openFDA)#

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