VELA SHAPE ACTIV BODY FIRMING TONING TIGHTENING- glycerin cream

Vela Shape ACTIV Body firming toning tightening by

Drug Labeling and Warnings

Vela Shape ACTIV Body firming toning tightening by is a Otc medication manufactured, distributed, or labeled by EZEKIELCOSMETIC CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

glycerin

INACTIVE INGREDIENT

water, menthol, caffeine etc

PURPOSE

a complete regimen for restorative body shape

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Apply suitable amount of the formula to each area of the body which can include arms, thighs, stomach and/or buttocks and vigorously massage VELA SHAPE RESCULPTING GEL over the targeted areas in a circular motion until full absorption occurs.

WARNINGS

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VELA SHAPE ACTIV BODY FIRMING TONING TIGHTENING 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71588-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CAFFEINE (UNII: 3G6A5W338E)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71588-0009-1	150 mL in 1 TUBE; Type 0: Not a Combination Product	08/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	08/17/2017

Labeler - EZEKIELCOSMETIC CO., LTD (689851966)

Registrant - EZEKIELCOSMETIC CO., LTD (689851966)

Establishment
Name	Address	ID/FEI	Business Operations
EZEKIELCOSMETIC CO., LTD		689851966	label(71588-0009) , manufacture(71588-0009) , pack(71588-0009)