Active Ingredient
Glycerin
Truezyme Baby Face And Body
FDA Label NDC 71076-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Truezyme Co., Ltd. for the product Truezyme Baby Face And Body (NDC 71076-0001). 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 active ingredient, purpose, dosage & administration, indications & usage, inactive ingredients:, otc - keep out of reach of children, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Dosage & Administration
For external use only
Indications & Usage
Apply to baby's face and body evenly after a bath or washing.
Apply to dry, rough-textured area repeatedly.
Use with Truezyme Baby Shampoo & Body Wash for better results.
Inactive Ingredients:
Sea Water, Caprylic/Capric Triglyceride, Propanediol, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter, etc.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Warnings
1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms.
1) If there are red spots, swelling, itchiness, or irritation
2) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight.
2. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.
3. If it gets into eye, wash the eye with clean water immediately.
4. Those who are allergic to certain medicinal herb, such as pollen and tangerine, must stop using the product if they experience hypersensitivity.
5. Precautions on storage and handling
1) Make sure to close the cap after use.
2) Keep out of the reach of children.
3) Do not keep the product in a hot or cold place or a place getting direct sunlight.
Package Label.Principal Display Panel
1 (Label)
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