MINI BLING POCKET HAIR PACK- dimethicone patch 
TONYMOLY CO.,LTD

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.

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ACTIVE INGREDIENT

Active Ingredient: DIMETHICONE 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: WATER, GLYCERIN, MINERAL OIL, CETEARYL ALCOHOL, PROPYLENE GLYCOL, BUTYLENE GLYCOL, MICROCRYSTALLINE WAX, POLYSORBATE 60, BUTYROSPERMUM PARKII (SHEA) BUTTER, CARBOMER, TRIETHANOLAMINE, NATTO GUM, HYDROLYZED SILK, HYDROLYZED SOY PROTEIN, OLEA EUROPAEA (OLIVE) FRUIT OIL, ARGANIA SPINOSA KERNEL OIL, SODIUM HYALURONATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) EXTRACT, MONARDA DIDYMA LEAF EXTRACT, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, FREESIA REFRACTA EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, HYDROLYZED COLLAGEN, ROYAL JELLY EXTRACT, AMINOPROPYL DIMETHICONE, GLYCINE, GLUTAMIC ACID, LYSINE HCL, SERINE, ASPARTIC ACID, PROLINE, LEUCINE, ARGININE, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, CHLORPHENESIN, ETHYLPARABEN, DISODIUM EDTA, FRAGRANCE

PURPOSE

Purpose: Scalp Protectant

WARNINGS

Warnings: For external use only When using this product do not get into eyes, Stop use and ask a doctor if rash occurs Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Use

Use: Helps prevent and relieve chapped or cracked skin

Directions

Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of pouch

MINI BLING POCKET HAIR PACK 
dimethicone patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-321
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.16 g  in 8 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-321-018 g in 1 POUCH; Type 0: Not a Combination Product08/15/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/15/2016
Labeler - TONYMOLY CO.,LTD (688216798)
Registrant - TONYMOLY CO.,LTD (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO.,LTD688216798manufacture(59078-321)

Revised: 9/2016
Document Id: 06804983-bbf7-4056-8537-aa89f97811b3
Set id: 6ec934f8-c96a-44b8-94b5-99df0ec87c35
Version: 1
Effective Time: 20160919
 
TONYMOLY CO.,LTD