THERA MOISTURIZING BODY- dimethicone cream

THERA Moisturizing Body by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Dimethicone 1.75%

Purpose

Skin Protectant

Keep out of reach of children

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

Uses

• Temporarily protects and helps relieve chapped or cracked skin. Benificial for face, hands, body and legs.

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 cream liberally as needed

Other information

• Protect from freezing. Avoid excessive heat.

Inactive ingredients

Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, SAFFLEXTM (Consisting of: Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E)), Bisabolol, Butylene Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Dimethicone Crosspolymer, Disodium EDTA, Glycerin, Glyceryl Stearate, Lavender Ylang Fragrance, PEG-100 Stearate, Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate, Phenoxyethanol, Purified Water, Sodium Hyaluronate, Stearic Acid, Triethanolamine, Zingiber Officinale (Ginger) Root Extract.

Label (4 mL)

Carton

INGREDIENTS AND APPEARANCE

THERA MOISTURIZING BODY 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	17.5 uL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
KUKUI NUT OIL (UNII: TP11QR7B8R)
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)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
GINGER (UNII: C5529G5JPQ)
SAFFLOWER OIL (UNII: 65UEH262IS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0208-8	946 mL in 1 BOTTLE, PLASTIC
2	NDC: 68599-0208-4	118 mL in 1 TUBE
3	NDC: 68599-0208-1	144 in 1 CARTON
3		4 mL in 1 PACKET

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)

Registrant - PureTek Corporation (785961046)

Establishment
Name	Address	ID/FEI	Business Operations
PureTek Corporation		785961046	manufacture, label, pack, outsourcing human drug compounding, relabel, repack