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RENOKIN HAIR REVITALIZING by Caregen Co., Ltd.

Medically reviewed on March 7, 2018

Dosage form: solution
Ingredients: Allantoin 0.3mg in 60mL
Labeler: Caregen Co., Ltd.
NDC Code: 60716-030

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

Active ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive ingredients:
Water (Aqua), Alcohol, Glycerin, Isopropyl Alcohol, Phenoxyethanol, Ginkgo Biloba Leaf Extract, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Thuja Orientalis Extract, Disodium EDTA, Oligopeptide-54, Decapeptide-18, Serenoa Serrulata Fruit Extract, Polygala Tenuifolia Root Extract, Portulaca Oleracea Extract, Fragrance (Parfum), Decapeptide-10, Sodium Oleate, Retinyl Palmitate, Biotin

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warning:
For external use only, do not swallow.
In case of accidental ingestion, seek medical assistance.
Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and consult a doctor if rash or irritation occurs.
Do not apply directly to a wound or open cut.
Keep out of reach of children.
Store at room temperature (below 25C).

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

Directions:
Apply the solution on dry scalp after using RENOKIN Hair Revitalizing Shampoo and Conditioner. Gently shake the solution before use. Spray to the target scalp area and lightly massage with fingertips. Do not wash off for 3 hours.
Use every morning and night.

DOSAGE AND ADMINISTRATION

Directions:
Apply the solution on dry scalp after using RENOKIN Hair Revitalizing Shampoo and Conditioner.
Gently shake the solution before use.
Spray to the target scalp area and lightly massage with fingertips.
Do not wash off for 3 hours.
Use every morning and night.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RENOKIN HAIR REVITALIZING 
allantoin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60716-030
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (ALLANTOIN) Allantoin0.3 mg  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Alcohol 
Packaging
#Item CodePackage Description
1NDC:60716-030-0160 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/02/2014
Labeler - Caregen Co., Ltd. (689850365)
Registrant - Caregen Co., Ltd. (689850365)
Establishment
NameAddressID/FEIOperations
Caregen Co., Ltd.689850365manufacture(60716-030)

 
Caregen Co., Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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