THERA MOISTURIZING BODY CLEANSER- dimethicone liquid

THERA Moisturizing Body Cleanser by

Drug Labeling and Warnings

THERA Moisturizing Body Cleanser 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%

Uses

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
• cleanses, moisturizes, nourishes, and protects skin
• it can be used on face, body and perineal area

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 cleanser to damp cloth or to skin/perineal area and then gently wipe clean. No rinsing necessary.
• Apply as needed
  
• Apply a protectant cream as necessary

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, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetyl Alcohol, Chlorphenesin, Disodium EDTA, Glycerin, Glycine Soja (Soybean) Oil, Glyceryl Stearate, Lavender Ylang Fragrance, Linoleamindopropyl PG-Dimonium Chloride Phosphate, PEG-100 Stearate, Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate, Phenoxyethanol, Purified Water, Sodium Hyaluronate, Stearic Acid, Triethanolamine, Zingiber Officinale (Ginger) Root Extract.

Label (8 fl oz)

Label (32 fl oz)

INGREDIENTS AND APPEARANCE

THERA MOISTURIZING BODY CLEANSER 
dimethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0202
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)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SOYBEAN OIL (UNII: 241ATL177A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TROLAMINE (UNII: 9O3K93S3TK)
GINGER (UNII: C5529G5JPQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
SAFFLOWER OIL (UNII: 65UEH262IS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0202-6	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 68599-0202-8	946 mL in 1 BOTTLE, PLASTIC

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