RUT HAIR AGELESS CLINIC AMPOULE by EL RISE Corporation / Kolmar Korea Co.,LTD. Gwanjeong Factory

RUT HAIR AGELESS CLINIC AMPOULE by

Drug Labeling and Warnings

RUT HAIR AGELESS CLINIC AMPOULE by is a Otc medication manufactured, distributed, or labeled by EL RISE Corporation, Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RUT HAIR AGELESS CLINIC AMPOULE- salicylic acid, menthol, panthenol liquid 
EL RISE Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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INACTIVE INGREDIENTS

WATER, ALCOHOL DENAT., BUTYLENE GLYCOL, PEG-60 HYDROGENATED CASTOR OIL, 1,2-HEXANEDIOL, GLYCERIN, SODIUM CITRATE, PPG-2-DECETH-12, SODIUM CHLORIDE, ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, FRAGRANCE, ALLANTOIN, DISODIUM EDTA, MALT EXTRACT, SODIUM PCA, SODIUM LACTATE, NIACINAMIDE, ARGININE, ASPARTIC ACID, PCA, ALCOHOL, GLYCINE, ALANINE, SERINE, VALINE, BIFIDA FERMENT FILTRATE, LACTOBACILLUS FERMENT, LACTOCOCCUS FERMENT LYSATE, PALMITOYL TETRAPEPTIDE-20 AMIDE, STREPTOCOCCUS THERMOPHILUS FERMENT, ISOLEUCINE, PROLINE, THREONINE, HOUTTUYNIA CORDATA EXTRACT, HISTIDINE, PHENYLALANINE, BIOTIN, CAMELLIA SINENSIS LEAF EXTRACT, PERILLA FRUTESCENS LEAF EXTRACT, CETRARIA ISLANDICA EXTRACT, HEDERA HELIX (IVY) EXTRACT, VERONICA OFFICINALIS EXTRACT, EQUISETUM ARVENSE EXTRACT, PAEONIA ALBIFLORA ROOT EXTRACT, PRUNUS PERSICA (PEACH) FRUIT EXTRACT, SWERTIA JAPONICA EXTRACT, ALLIUM SATIVUM (GARLIC) BULB EXTRACT, GLYCINE MAX (SOYBEAN) SEED EXTRACT, HORDEUM VULGARE SEED EXTRACT, ORYZA SATIVA (RICE) EXTRACT, PANAX GINSENG ROOT EXTRACT, RIBES NIGRUM (BLACK CURRANT) FRUIT EXTRACT, RUBUS FRUTICOSUS (BLACKBERRY) FRUIT EXTRACT, SESAMUM INDICUM (SESAME) SEED EXTRACT, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, TUBER MELANOSPORUM EXTRACT, COPPER TRIPEPTIDE-1, ACETYL HEXAPEPTIDE-8, PALMITOYL PENTAPEPTIDE-4, PALMITOYL TETRAPEPTIDE-7, PALMITOYL TRIPEPTIDE-1

ACTIVE INGREDIENTS

SALICYLIC ACID 0.25%
MENTHOL 0.3%
PANTHENOL 0.2%

helps prevent hair loss and thicken hair

WARNINGS

For external use only When using this product
■ If following abnormal symptoms occurs after using the product, stop using the product and consult with a skin specialist. Symptoms : Red specks, swelling, itching
■ Do not use on the skin parts affected by wound, eczema, or dermatitis.
Keep out of reach of children.
■ If swallowed, get a medical help or contact a person in control center immediately.
■ Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN

■ If swallowed, get a medical help or contact a person in control center immediately.

Uses

■ Helps prevent hair loss and thicken hair

Directions

■ Apply at least once a day onto your damp or dry hair. Spray directly onto scalp one section at a time and gently massage to ensure even distribution. Do not rinse out. Repeat as desired

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RUT HAIR AGELESS CLINIC AMPOULE 
salicylic acid, menthol, panthenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82573-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.25 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.3 g  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82573-030-02	1 in 1 CARTON	06/11/2022	04/01/2023
1	NDC: 82573-030-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/11/2022	04/01/2023

Labeler - EL RISE Corporation (694486919)

Registrant - EL RISE Corporation (694486919)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(82573-030)

Revised: 4/2023

Document Id: fa365792-97c9-81c0-e053-6394a90a9a60

34390-5

Set id: e12613a7-9ad3-1962-e053-2a95a90a9af0

Version: 4

Effective Time: 20230426