VITABRID C12 SPOT SENSITIVE SOLUTION- zinc oxide liquid
HYUNDAI IBT 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.

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ACTIVE INGREDIENT

zinc oxide allantoin

INACTIVE INGREDIENT

ascorbic acid, glyceryl stearate, niacinamide, etc

PURPOSE

delivers active vitamin c deep into the skin to effectively clear and repair your skin

WARNINGS

Warnings: For external use only. Avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water. Do not apply to deep cuts, puncture wounds, animal bites, or serious burns. Keep out of reach of children. If swallowed, seek medical assistance or contact a Poison Control Center immediately. Stop use and ask a doctor if condition worsens or does not improve after regular use.

KEEP OUT OF REACH OF CHILDREN

Use

1. mix an appropriate amount of Vitabrid c12 Spot with one or two drops of a Vitabrid C12 Spot Ampoule in the palm of your hand

2. apply mixture to troubled areas

Directions

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

VITABRID C12 SPOT SENSITIVE SOLUTION
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70933-309
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0042 g in 100 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70933-309-01	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/15/2017	07/17/2017

Labeler - HYUNDAI IBT CO., LTD. (688277268)

Registrant - HYUNDAI IBT CO., LTD. (688277268)

Name	Address	ID/FEI	Business Operations
Establishment
HYUNDAI IBT CO., LTD.		688277268	manufacture(70933-309)

Revised: 7/2017

Document Id: 54932534-1a07-1cf8-e054-00144ff8d46c

Set id: 5451d383-243f-3d06-e054-00144ff88e88

Version: 2

Effective Time: 20170718

HYUNDAI IBT CO., LTD.