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Lucky

Delta Brands Inc

DRUG FACTS




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient
Dimethicone 1%

Purpose

Purpose
Skin protectant

Uses

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

Lucky

Lucky

dimethicone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:20276-044
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 1 g

Inactive Ingredients

Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:20276-044-12 355 in 1 BOTTLE, PLASTIC
2 NDC:20276-044-18 532 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2013-01-31


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