SEEONE BODY RELAX- vanillyl butyl ether, peppermint cream 
Rainbow Beauty Cosmetic

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.

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ACTIVE INGREDIENT

Active Ingredient: Vanillyl Butyl Ether 0.40%, Mentha Piperita (Peppermint) Oil 0.08%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Alcohol Denat., Propylene Glycol, Glycerin, Mineral Water, Carbomer, Phenoxyethanol, Chlorphenesin, Potassium Hydroxide, Butylene Glycol, Camellia Sinensis Leaf Extract, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Disodium EDTA, Emu Oil, Macadamia Integrifolia Seed Oil, Oryza Sativa (Rice) Bran Extract, Phellinus Linteus Extract

PURPOSE

Purpose: Muscle relaxation

WARNINGS

Warnings: If the following signs occur please stop using immediately and consult a dermatologist. stop using if skin becomes red, swollen, itchy and etc during and after use. Avoid using on irritated or sunburned skin by direct sunlight. For areas with infection or high inflammatory activity, do not use. Storage and Handling Precautions. Put the lid back on after you have used it. Keep away from the reach of baby and children. Do not keep places of the high temperature or low temperature and direct sunlight.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & usage: After shower or when feeling skin dry, amount on your hands. And then massage myalgia point, a few minutes.

DOSAGE & ADMINISTRATION

Dosage & Administration: When used day and night, relaxation the appearance of myalgia point.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SEEONE BODY RELAX 
vanillyl butyl ether, peppermint cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71193-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R) (VANILLYL BUTYL ETHER - UNII:S2ULN37C9R) VANILLYL BUTYL ETHER0.48 g  in 120 mL
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL0.09 g  in 120 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71193-010-021 in 1 CARTON12/01/2016
1NDC:71193-010-01120 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/2016
Labeler - Rainbow Beauty Cosmetic (690444706)
Registrant - Rainbow Beauty Cosmetic (690444706)
Establishment
NameAddressID/FEIBusiness Operations
Rainbow Beauty Cosmetic690444706manufacture(71193-010)

Revised: 1/2017
Document Id: 895c6940-e1a5-45a9-9026-7890a5d080e8
Set id: c7be9522-054e-4dad-99f3-e15eb6fe84b9
Version: 1
Effective Time: 20170120
 
Rainbow Beauty Cosmetic