Hesol Rim: Package Insert and Label Information

HESOL RIM — salicylic acid and niacinamide gel
Ecomine Co Ltd

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.

Drug Facts

Active Ingredient
Salicylic Acid 0.10%
Niacinamide 0.20%

Purpose

Hair Tonic

Keep out of Reach of Children

Stop use and ask a doctor if
– chest pain, rapid heartbeat, faintness, or dizziness occurs
– your hands or feet swell
– scalp irritation or redness occurs
– May be harmful if used when pregnant or breast-feeding
– Keep out of reach of children if swallowed, get medical help or Poison Control Center right away

Indication & Usage

When using this product
– do not apply on other parts of the body
– avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water
– some people have experienced changes in hair color and/or texture
– it takes time to regrow hair
– the amount of hair regrowth is different for each person. This product will not work for everyone.

Warnings

For external use only
Do not use
– your scalp is red, inflamed, infected, irritated, or painful
– you have no family history of hair loss
– your hair loss is sudden and/or patchy
– your hair loss is associated with childbirth
– you do not know the reason for your hair loss
-you are under 18 years of age. Do not use on babies and children Ask adoctor before use if you have heart disease

Dosage & Administration

– shake well before using product
– apply an appropriate amount all over scalp every day
– scrub and massage scalp using hands for helping to absorb product
Other information
– before use, read all information on carton and enclosed booklet
– store at controlled room temperature 1 to 30℃
– Do not store in hot locations or expose to sunlight

Inactive Ingredient

Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Water, Cocamidopropyl Betaine, Betain, Dimethicone, Laureth-23, Laureth-2

Hesol Rim Shampoo

Ecomine Co LtdNet WT. 10.2 FL OZ (300mL)

image of carton label
(click image for full-size original)
HESOL RIM salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51270-111
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.3 mL in 300 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 0.6 mL in 300 mL
Inactive Ingredients
Ingredient Name Strength
AMMONIUM LAURYL SULFATE
SODIUM LAURETH SULFATE
WATER
COCAMIDOPROPYL BETAINE
BETAINE
GREEN TEA LEAF
DIMETHICONE
LAURETH-23
LAURETH-2
PROPYLENE GLYCOL
GLYCERIN
GLYCOL STEARATE
EQUISETUM ARVENSE TOP
SAW PALMETTO
URTICA DIOICA
POLYQUATERNIUM-10 (400 CPS AT 2%)
LAURIC DIETHANOLAMIDE
CETYL ALCOHOL
MENTHOL
.ALPHA.-TOCOPHEROL ACETATE, D-
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
EDETATE DISODIUM
TRIHYDROXYSTEARIN
GINGER OIL
Product Characteristics
Color brown (yellow brown) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51270-111-02 1 BOTTLE (BOTTLE) in 1 BOX contains a BOTTLE (51270-111-01)
1 NDC:51270-111-01 300 mL in 1 BOTTLE This package is contained within the BOX (51270-111-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2010
Labeler — Ecomine Co Ltd (557795691)
Registrant — Ecomine Co Ltd (557795691)
Establishment
Name Address ID/FEI Operations
Ecomine Co Ltd 557795691 manufacture

Revised: 10/2010 Ecomine Co Ltd

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