Assured
FDA Label NDC 58194-039

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Weierya Daily Chemicals Factory for the product Assured (NDC 58194-039). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient

Sodium Bicarbonate (Baking Soda) 5%

Otc - Purpose

Purpose

Skin Protectant

Indications & Usage

Uses   temporary relief of itching and irritation due to

-insect bites and stings  -poison ivy, oak or sumac

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • over large areas of the body
  • other than as directed

Otc - When Using

When using this product

  • avoid contact with eyes

Otc - Stop Use

Stop use and ask a doctor if

  • symptoms last for more than 7 days
  • the condition becomes worse
  • symptoms clear up and then occur again within a few days

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 over 2 years of age:

-apply a small amount of directly to the bite, sting or affected

area and rub gently

-re-apply as needed

children under 2 years of age: ask a doctor before use

Storage And Handling

Other information

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

Inactive Ingredient

Inactive ingredients   ammonia, cyclohexasiloxane,

cyclopentasiloxane, glycerin, water

Description

Assured's Bug Bite Relief helps to relieve a wide range

of irritation and itching associated with the most common

and annoying insect bites. When you feel the sting, reach

for the soothing relief of Assured's Bug Bite Relief.

Easy. Convenient. Effective.

Always keep it with you. On - the - go or at home.

Package Label.Principal Display Panel

Copy Of Label (Pen Label)

Copy Of Label (Pen Label)

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