RENOKIN HAIR REVITALIZING- allantoin shampoo

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), Sodium Laureth Sulfate, Ammonium Lauryl Sulfate, Cocamide DEA, Cocamidopropyl Betaine, Polyquaternium-7, Glycerin, Polygonum Multiflorum Root Extract, Thuja Orientalis Extract, Polygala Tenuifolia Root Extract, Hydroxypropyltrimonium Hydrolyzed Silk, Hydrolyzed Keratin, Silicone Quaternium-16, Bis (C13-15 Alkoxy) PG-Amodimethicone, Undeceth-11, PEG-150 Pentaerythrityl Tetrastearate, PEG-6 Caprylic/Capric Glycerides, Arginine, Polyquaternium-10, Phenoxyethanol, Sodium Chloride, Menthol, Butyloctanol, Citric Acid, Panthenol, Sodium Benzoate, Niacinamide, Hydrogenated Lecithin, Glycine Soja (Soybean) Oil, Fragrance (Parfum), Tetrasodium EDTA, Benzophenone-5, Biotin, Acid Violet 43 (CI 60730), Yellow 6 (CI 15985), Decapeptide-10, Octapeptide-2, Oligopeptide-54, Decapeptide-18

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:
Wet hair thoroughly, gently lather shampoo throughout hair and scalp.
Gently massage scalp for 15 seconds. Leave on hair for 30 seconds and rinse out.

DOSAGE AND ADMINISTRATION

Directions:
Wet hair thoroughly, gently lather shampoo throughout hair and scalp.
Gently massage scalp for 15 seconds. Leave on hair for 30 seconds and rinse out.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RENOKIN HAIR REVITALIZING 
allantoin shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60716-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.75 mg  in 150 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60716-010-01	150 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(60716-010)