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VELVET ON THE GROUND

Dosage form: liquid
Ingredients: Allantoin 0.02g in 4mL
Labeler: Prostemics Co., Ltd.
NDC Code: 62041-140

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.

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Deer Antler Cell/sh-Polypeptide-1 Conditioned Media, 1,2-Hexanediol, Butylene Glycol, Houttuynia Cordata Extract, Niacinamide, Panthenol, Glycerin, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Caprylyl Glycol, Copper Tripeptide-1, Polygonum Multiflorum Root Extract, Sophora Angustifolia Root Extract, Phenoxyethanol, Acorus Calamus Root Extract, Tropolone, Hydrolyzed Collagen, Menthol, Disodium EDTA

PURPOSE

Purpose: Scalp Protectant

WARNINGS

Warnings: 1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist. 1) In case of having problems such as red spots, swelling, itching or irritation during using this product, 2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight. 2. Do not use it on the part where you have a scar, eczema or dermatitis. 3. Do not put it in extremely hot or cold places or where exposed to direct sunlight. 4. Topical use only. 5. Store at room temperature. 6. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & usage: 1. Cleans your hair and scalp with Velvet on the groundᵀᴹ No-too-late shampoo for gentle exfoliation of the scalp preparation. 2. Unscrew the silver tip of grow glow ampoule counter clockwise to open the dropper-system cap and apply one ampoule to scalp directly. 3. The treatment of Velvet on the groundᵀᴹ grow glow ampoule can also apply with LED devices for an after-use program.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product. Apply one or two times a week. Single Use Only.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VELVET ON THE GROUND 
allantoin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62041-140
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (ALLANTOIN) Allantoin0.02 g  in 4 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Butylene Glycol 
Packaging
#Item CodePackage Description
1NDC:62041-140-0212 BOTTLE in 1 CARTON
1NDC:62041-140-014 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/2016
Labeler - Prostemics Co., Ltd. (689605919)
Registrant - Prostemics Co., Ltd. (689605919)
Establishment
NameAddressID/FEIOperations
Prostemics Co., Ltd.689605919manufacture(62041-140)

Revised: 09/2016
 
Prostemics Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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