THERA ANTIMICROBIAL BODY CLEANSER- benzalkonium chloride liquid

THERA Antimicrobial Body Cleanser by

Drug Labeling and Warnings

THERA Antimicrobial 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

Benzalkonium Chloride  0.13%

Purpose

Antiseptic

Keep out of reach of children.

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

Uses

• a no-rinse topical antiseptic that reduces and inhibits bacterial growth.
  

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

• Spray soiled and/or odorous (body and/or perineal) areas
• Gently wipe clean
• Repeat as necessary until all soils are removed and skin is clean
• Pat dry. No rinsing necessary.
• Apply a protectant cream or paste as necessary
  

Other information

• Protect from freezing. Avoid excessive heat.
  

Inactive ingredients

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, Disodium EDTA, Glycerin, Lavender Ylang Fragrance, Phenoxyethanol, Polysorbate 20, Purified Water, Sodium Hyaluronate, Sodium Hydroxide, Zingiber Officinale (Ginger) Root Extract.

Label (4 fl oz)

Label (8 fl oz)

INGREDIENTS AND APPEARANCE

THERA ANTIMICROBIAL BODY CLEANSER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 uL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
NIACINAMIDE (UNII: 25X51I8RD4)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GINGER (UNII: C5529G5JPQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0201-4	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 68599-0201-6	237 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	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