Otc - Active Ingredient
Active ingredient
Sodium Bicarbonate (Baking Soda) 5%
Skin Protectant
FDA Label NDC 31190-101
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 Kejing Cleaning Products Co., Ltd. for the product Skin Protectant (NDC 31190-101). 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 - 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 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 over 2 years of age:
-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 - 86F (15 - 30C)
Inactive Ingredient
Inactive ingredients ammonia, cyclohexasiloxane,
cyclopentasiloxane, glycerin, water
Package Label.Principal Display Panel
Copy Of Label (Bite Label)
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