OTC Medication Information: K.vi Zero Sanitizer

K.VI ZERO SANITIZER- alcohol gel
HWAJIN BIO COSMETICS 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.

ACTIVE INGREDIENT

ETHANOL 70% w/w

INACTIVE INGREDIENTS

Water, Glycerin, Aloe Vera Gel, Mulberry Root Extract, Carbomer, Triethanolamine, Fragrance

PURPOSE

Hand Sanitizer

WARNINGS

For external use only. Flammable. Keep away from heat or flame.
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Do not use
• In children less than 2 months of age
• On open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Instant hand sanitizer to reduce bacteria on the skin.

Directions

• Apply product onto clean and dry hands.
• Rub hands together covering all surfaces of hands and fingers until it is absorbed.
• Children should be supervised when using.

Other information

• Store between 1-30°C (34-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

PACKAGE LABEL : K.vi-zero Sanitizer Gel

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K.VI ZERO SANITIZER
ethanol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78394-030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 35 g in 50 g
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
ALOE VERA LEAF
MORUS ALBA ROOT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78394-030-01 50 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 06/01/2020
Labeler — HWAJIN BIO COSMETICS CO., LTD. (688012988)
Registrant — HWAJIN BIO COSMETICS CO., LTD. (688012988)
Establishment
Name Address ID/FEI Operations
HWAJIN BIO COSMETICS CO., LTD. 688012988 manufacture (78394-030)

Revised: 06/2020 HWAJIN BIO COSMETICS 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.

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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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