Label: TRUEZYME ACTIVE ENZYME SCALP AND HAIR- glycerin shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 71076-0004-1 - 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 16, 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
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
- Wet the scalp and hair evenly and spray the product directly over the scalp and lather well. Massage the scalp with fingertips gently and wash with warm water enough,
- Leave for 2 or 3 minutes and then wash for better results.
- Shampoo twice after dyeing or chemical treatment for better results.
* Shake well before use.
- Inactive ingredients:
- KEEP OUT OF REACH OF CHILDREN
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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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRUEZYME ACTIVE ENZYME SCALP AND HAIR
glycerin shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71076-0004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength PANTHENOL (UNII: WV9CM0O67Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71076-0004-1 300 mL in 1 BOTTLE; 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(71076-0004)
