Assured
FDA Label NDC 71537-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Huijing (shanghai) Bio-tech Co., Ltd for the product Assured (NDC 71537-005). 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 - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, 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.

Do not use

•over large areas of the body

•other than as directed

When using this product

•avoid contact with eyes

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 2 years of age and over:

•apply a small amount 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

Package Label.Principal Display Panel

Image Description (Bug 005)

Image Description (Bug 005)

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