Label: HASOL REVITALIZING TREATMENT- dimethicone gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51270-115-01 - Packager: Ecomine Co Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 1, 2013
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Drug Facts
Active ingredient
Dimethicone 1.00%
Keep out of Reach of children
Stop use and ask a doctor if scalp is inflamed, infected, irritated, redness or painful.
Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.
Indication & Usage
Directions
■ After shampoo, apply an appropriate amount to the end of hair.
■ Gently massaging into moisten hair.
■ Wash with tepid water.Warnings
Warnings
For external use only
Do not use ■ If you use other medications on the scalp.
■ On damaged or broken skinWhen using this product
■ Do not apply on other parts of the body
■ Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
Dosage & Administration
Uses ■ This product is fortified with nutrients for the hair, helps to make hair smooth and shine.
Inactive ingredient
Water, Cetearyl alcohol, Glycerin, Behentrimonium chloride, Cetyl alcohol, Glyceryl stearate, Laureth-3, Laureth-23, Fragrance, Chlorphenesin, Pinus sylvestris leaf oil, Solanum lycopersicum (tomato) fruit extract, Beta-glucan, Phenoxyethanol, Melaleuca alternifolia(tea tree) leaf oil, Lycopene, Citric acid, Rehmannia glutinosa root extract, Cornus officinalis fruit extract, Dioscorea japonica root extract, Alisma plantago aquatica extract, Paeonia suffruticosa root extract, Poria cocos extract, Panax ginseng root extract, Juglans regia(walnut) seed extract, Punica granatum fruit extract, Camellia sinensis leaf extract, Swertia japonica extract, Glycine max(soybean) seed extract
- Hasol Revitalizing Treatment
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INGREDIENTS AND APPEARANCE
HASOL REVITALIZING TREATMENT
dimethicone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51270-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.0 g in 300 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LAURETH-3 (UNII: F32E4CB0UJ) LAURETH-23 (UNII: N72LMW566G) CHLORPHENESIN (UNII: I670DAL4SZ) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) TOMATO (UNII: Z4KHF2C175) PHENOXYETHANOL (UNII: HIE492ZZ3T) TEA TREE OIL (UNII: VIF565UC2G) LYCOPENE (UNII: SB0N2N0WV6) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ) CORNUS OFFICINALIS FRUIT (UNII: 23NL8NQ187) DIOSCOREA JAPONICA TUBER (UNII: I43FCF3356) ALISMA PLANTAGO-AQUATICA TOP (UNII: 321GB7FW2H) PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J) FU LING (UNII: XH37TWY5O4) ASIAN GINSENG (UNII: CUQ3A77YXI) ENGLISH WALNUT (UNII: 1V3SHR7QB7) POMEGRANATE (UNII: 56687D1Z4D) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SWERTIA JAPONICA (UNII: 01X0P6GX6C) SOYBEAN (UNII: L7HT8F1ZOD) Product Characteristics Color white (black) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51270-115-01 300 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/01/2013 Labeler - Ecomine Co Ltd (557795691) Registrant - Ecomine Co Ltd (557795691) Establishment Name Address ID/FEI Business Operations Ecomine Co Ltd 557795691 manufacture(51270-115)
