RENOKIN HAIR REVITALIZING- allantoin solution

RENOKIN HAIR REVITALIZING by

Drug Labeling and Warnings

RENOKIN HAIR REVITALIZING by is a Otc medication manufactured, distributed, or labeled by Caregen Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

RENOKIN HAIR REVITALIZING 
allantoin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60716-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.3 mg  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60716-030-01	60 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/02/2014

Labeler - Caregen Co., Ltd. (689850365)

Registrant - Caregen Co., Ltd. (689850365)

Establishment
Name	Address	ID/FEI	Business Operations
Caregen Co., Ltd.		689850365	manufacture(60716-030)