THERA MOISTURIZING BODY SHIELD- dimethicone cream

THERA Moisturizing Body Shield by

Drug Labeling and Warnings

THERA Moisturizing Body Shield by is a Otc medication manufactured, distributed, or labeled by McKesson Medical-Surgical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

• Dimethicone 1.5%
  

Purpose

• Skin Protectant
  

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away.

Uses

• For the treatment and/or prevention of diaper rash
• Temporarily protects and helps relieve chapped or cracked skin
  

Warnings

• For external use only
  

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

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
  

Directions

• Apply liberally as needed

Inactive ingredients

• Protect from freezing. Avoid excessive heat.

Inactive ingredients

• Aleurites Moluccana Seed Oil,
• Aloe Barbadensis (Aloe Vera) Lead Juice,
• SAFFLEX TM (Consisting of:
• Calcium Pantothenate (Vitamin B 5),
• Maltodextrin, Niacinamide (Vitamin B 3),
• Pyridoxine HCl (Vitamin B 6),
• Silica,
• Sodium Ascorbyl Phosphate (Vitamin C),
• Sodium Starch Octenylsuccinate,
• Tocopheryl Acetate (Vitamin E)),
• Bisabolol,
• C12-13 Pareth-23,
• C12-13 Pareth-3,
• Carthamus Tinctorius (Safflower) Oleosomes,
• Carthamus Tinctorius (Safflower) Seed Oil,
• Cetyl Dimethicone,
• Clyclopentasiloxane,
• Dicaprylyl Carbonate,
• Dimethiconol,
• Divinyldimethicone/Dimethicone Copolymer,
• Lavender Ylang Fragrance,
• PEG/PPG-18/18 Dimethicone,
• Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate,
• Phenoxyethanol,
• Propylene Glycol,
• Propylheptyl Caprylate,
• Purified Water,
• Sodium Chloride,
• Sodium Hyaluronate,
• Zingiber Officinal (Ginger) Root Extract.

Label (4 oz)

NDC: 68599-0204-4

Thera

Moisturizing Body Shield

Net Contents 4 fl oz (118 mL)

MFR# 53-MS4

Label (4g)

NDC: 68599-0204-1

Thera

Moisturizing Body Shield

Net Contents 4 g (0.14 oz)

MFR# 53-MS4G

INGREDIENTS AND APPEARANCE

THERA MOISTURIZING BODY SHIELD 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
KUKUI NUT (UNII: J87WJ3E7VW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
NIACINAMIDE (UNII: 25X51I8RD4)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LEVOMENOL (UNII: 24WE03BX2T)
SAFFLOWER OIL (UNII: 65UEH262IS)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GINGER (UNII: C5529G5JPQ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0204-4	113 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2011
2	NDC: 68599-0204-1	144 in 1 CARTON	09/01/2011
2		4 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2011

Labeler - McKesson Medical-Surgical Inc. (023904428)