Cell Acher Sports Body Massage: Package Insert and Label Information

CELL ACHER SPORTS BODY MASSAGE- vanillyl butyl ether cream
Natuzen Co., Ltd

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.

ACTIVE INGREDIENT

Active Ingredient: VANILLYL BUTYL ETHER 1.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Alcohol Denat., 1,2-Hexanediol, Propylene Glycol, Triethanolamine, Carbomer, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, MenthaPiperita (Peppermint) Oil, Polyacrylamide, C13-14 Isoparaffin, Emu Oil, OleaEuropaea (Olive) Fruit Oil, Macadamia Ternifolia Seed Oil, Laureth-7

PURPOSE

Purpose: Topical Analgesic

WARNINGS

Warnings: If you find such symptoms while using this product, stop using it and consult with a doctor. 1. If you find red spots, swelling or itching on the applied area, stop using it. Do not apply this product on the burned skin. Do not apply this product on the area which has cut, scratch, eczema or dermatitis. For external use only Avoid contact with eyes.

Storage and Handling

Close the lid after using it. Keep this product out of the reach of children. Do not keep this product in the place where is extremely hot or cold.

KEEP OUT OF REACH OF CHILDREN

Keep this product out of the reach of children.

INDICATIONS & USAGE

Features: This is a sports massage cream which helps to relieve pain on muscles and joints after a workout. A gradual heat delivers comforts on your muscles and joints. It gives you fresh usability without being sticky.

Usage: The cream is an anti-inflammatory pain relieving and topical analgesic ointment that is intended to relieve muscle and joint pain associated with arthritis, rheumatalgia, backaches, knee pain and shoulder pain.

DOSAGE & ADMINISTRATION

Directions: Use only as directed. 1. Apply to adults and children 12 Years of age and older. 2. Apply on the necessary area not more than 3 to 4 times daily. 3. Apply proper amount of Cell Acher Sports Body Massage Cream on the necessary area. 4. Put proper amount of cream on the necessary area and rub it. 5. If you need more heat, apply more amount of cream.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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CELL ACHER SPORTS BODY MASSAGE
vanillyl butyl ether cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70930-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANILLYL BUTYL ETHER (VANILLYL BUTYL ETHER) VANILLYL BUTYL ETHER 1.53 g in 153 g
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70930-010-02 1 TUBE in 1 CARTON contains a TUBE (70930-010-01)
1 NDC:70930-010-01 153 g in 1 TUBE This package is contained within the CARTON (70930-010-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2016
Labeler — Natuzen Co., Ltd (688201272)
Registrant — Natuzen Co., Ltd (688201272)
Establishment
Name Address ID/FEI Operations
Natuzen Co., Ltd 688201272 manufacture (70930-010)

Revised: 09/2016 Natuzen Co., Ltd

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