OTC Medication Information: Vela Shape Reaffirming Body Firming Toning Tightening

VELA SHAPE REAFFIRMING BODY FIRMING TONING TIGHTENING- glycerin liquid
EZEKIELCOSMETIC CO., LTD

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.

glycerin

wter butylene glycol, adenosine etc

a complete regimen for restorative body shape

keep out of reach of the children

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

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.

for external use only

label
(click image for full-size original)

VELA SHAPE REAFFIRMING BODY FIRMING TONING TIGHTENING
glycerin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71588-0008
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 15 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CAFFEINE
BUTYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71588-0008-1 150 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 08/17/2017
Labeler — EZEKIELCOSMETIC CO., LTD (689851966)
Registrant — EZEKIELCOSMETIC CO., LTD (689851966)
Establishment
Name Address ID/FEI Operations
EZEKIELCOSMETIC CO., LTD 689851966 manufacture (71588-0008), pack (71588-0008), label (71588-0008)

Revised: 08/2017 EZEKIELCOSMETIC CO., LTD

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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