Otc - Active Ingredient
Glycerin
Truezyme Baby Shampooandbody Wash
FDA Label NDC 71076-0002
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 Shampooandbody Wash (NDC 71076-0002). 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, inactive ingredient, warnings, indications & usage, otc - keep out of reach of children, dosage & administration, 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
Otc - Purpose
Cleanse, moisturize, and smoothen sensitive baby's skin gently.
Inactive Ingredient
Sea Water, Water, Lauryl Glucoside, Decyl Glucoside, Pentylene Glycol, Laminaria Japonica Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Butylene Glycol, Panthenol, etc.
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. Wash away with water enough after use since not enough rinsing can lead to hair loss or discoloration.
5. Those who are allergic to certain medicinal herb, such as pollen and tangerine, must stop using the product if they experience hypersensitivity. 6. 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.
Indications & Usage
- Wet the whole body and lather well on a shower sponge, a towel, or hands and massage the whole body gently and wash away with water cleanly.
- For a bath, you can enjoy a refreshing enzymatic bath by lathering enough in warm water.
* Shake well before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
For the external use only
Package Label.Principal Display Panel
1 (Label)
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