Label: ZNSP AMPOULE- glycerin solution
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Contains inactivated NDC Code(s)
NDC Code(s): 70749-010-01, 70749-010-02 - Packager: Z-TON ES BIO 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 June 2, 2016
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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WARNINGS
Warnings: 1. It is recommended to stop applying and consult a doctor immediately if you are suffering such conditions A) In case of rash, swell-up, itchiness B) If applied part is suffering conditions above on direct exposure to sunlight 2. Do not apply directly to wound or open cut 3. Cautions on storage A) Keep the cap sealed B) Away from children C) Do not leave it on high, low temperature or exposed on sunlight
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Indications & usage: 1. Carefully open the ampoule
2-1. Without compressor: Apply an appropriate amount of the product on the clean face skin. Gently smooth over entire face to help the absorption of the product.
2-2. With compressor: insert one ampoule into compressor and gently spray it all over the face.
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZNSP AMPOULE
glycerin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70749-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.25 g in 5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70749-010-02 15 in 1 CARTON 05/01/2016 1 NDC:70749-010-01 5 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/01/2016 Labeler - Z-TON ES BIO CO., LTD. (689847169) Registrant - Z-TON ES BIO CO., LTD. (689847169) Establishment Name Address ID/FEI Business Operations Z-TON ES BIO CO., LTD. 689847169 manufacture(70749-010)