Label: IM V-TOX- glycerin patch
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Contains inactivated NDC Code(s)
NDC Code(s): 70514-0011-1 - Packager: Karatica Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 15, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
1) Open the pouch and take the patch out. Then remove the transparent film.
2) Center the patch on your chin. Then hang the earloop on both ears after gently stretching the patch to fit your face.
3) Remove the patch after 15~20 mins, then gently pat to finish.
*Tip: Recommend to use 2~3 times a week. Use daily for better results.
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WARNINGS
1) Discontinue use or consult dermatologist if irritation, itching or swelling appears after applying the product.
2) Avoid applying patches on the wounded, inflamed skin.
3) Cautions for the storage and handling
a) Keep out of children.
B) Avoid direct sunlight.
c) Avoid applying around eyes.
* Wearing satisfaction and the results may vary depending on the person.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IM V-TOX
glycerin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70514-0011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 20 g in 100 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70514-0011-1 5 in 1 PACKAGE 03/16/2018 1 13 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/16/2018 Labeler - Karatica Co., Ltd (689605545) Registrant - Karatica Co., Ltd (689605545) Establishment Name Address ID/FEI Business Operations Karatica Co., Ltd 689605545 manufacture(70514-0011) , label(70514-0011) , pack(70514-0011)