LUCKY  DAILY MOISTURIZING- dimethicone lotion 
Delta Brands Inc

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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DRUG FACTS

Active Ingredient
Dimethicone 1%

Purpose
Skin protectant

Uses

■Helps prevent and temporarily protects chafed, chapped, or cracked skin

■Helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product

■Do not get into eyes

Stop use and ask a doctor if

■Condition worsens

■Symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on

■Deep or puncture wounds

■Animal bites

■Serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions Apply as needed

Inactive ingredients avena sativa (oat) kernel flour, benzyl alcohol, carbomer, ceteareth-20, cetrimonium chloride, cetearyl alcohol, FD&C blue no.1, FD&C yellow no.5, FD&C yellow no.6, glycerin, methylchloroisothiazolinone, methylisothiazolinone, mineral oil, petrolatum, p glycol, triethanolamine, tocopheryl acetate, water

Product Label

image description

LUCKY   DAILY MOISTURIZING
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:20276-044
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AVENA SATIVA FLOWERING TOP 
BENZYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
CETOSTEARYL ALCOHOL 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
FD&C YELLOW NO. 6 
GLYCERIN 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
MINERAL OIL 
PETROLATUM 
TROLAMINE 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-044-12355 mL in 1 BOTTLE, PLASTIC
2NDC:20276-044-18532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/31/2013
Labeler - Delta Brands Inc (102672008)
Establishment
NameAddressID/FEIBusiness Operations
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil566220234manufacture(20276-044)

Revised: 1/2013
Document Id: 0df090c9-af5e-480c-b218-aea60e3fab64
Set id: 76ac2257-a54c-4c6a-8a30-b5f89e0bbc42
Version: 1
Effective Time: 20130124
 
Delta Brands Inc