Label: TRUEZYME BABY SHAMPOOANDBODY WASH- glycerin liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 71076-0002-1 - Packager: Truezyme Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 15, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INACTIVE INGREDIENT
-
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
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TRUEZYME BABY SHAMPOOANDBODY WASH
glycerin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71076-0002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 3.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PANTHENOL (UNII: WV9CM0O67Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71076-0002-1 300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2016 Labeler - Truezyme Co., Ltd. (693938262) Establishment Name Address ID/FEI Business Operations Truezyme Co., Ltd. 693938262 manufacture(71076-0002)
