Assured Gel
FDA Label NDC 55621-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Jingwei Pharmaceutical Co., Ltd. for the product Assured (NDC 55621-010). 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 inactive ingredient, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Inactive Ingredient

Inactive Ingredients  aloe barbadensis leaf juice, carbomer 940,

glycerin, menthol, methylparaben, polyethylene glycol 400,

propylene glycol, propylparaben, triethanolamine, water

Otc - Active Ingredient

Active Ingredient

Lidocaine hydrochloride 2.5 %

Otc - Purpose

Purpose

Topical analgesic

Indications & Usage

Uses  for temporary relief of pain associated with

- minor burns

- sunburn

- minor cuts or scrapes

- minor skin irritations

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

- in large quantities, particularly over raw surfaces

or blistered areas

Otc - When Using

When using this product

- avoid contact with eyes

Otc - Stop Use

Stop use and ask a doctor if

- 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

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

or contact a Poison Control Center right away

Dosage & Administration

Directions

adults and children under 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 udner 2 years of age: consult a physician

Storage And Handling

Other Information

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

Package Label.Principal Display Panel

Copy Of Label (Burn 01001)

Copy Of Label (Burn 01001)

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