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 Type HUMAN OTC DRUG Item Code (Source) NDC:20276-044
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:20276-044-12 355 mL in 1 BOTTLE, PLASTIC
2 NDC:20276-044-18 532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/31/2013
Labeler - Delta Brands Inc (102672008)
Establishment
Name Address ID/FEI Business Operations
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil 566220234 manufacture(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