Your browser does not support JavaScript! THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]
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THERA CALAZINC BODY SHIELD (zinc oxide) paste
[McKesson Medical-Surgical Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredient

Zinc Oxide 20.0% (3.0% as Calamine)

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 minor skin irritation and itching due to rashes

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


  • Cleanse skin with THERATM Moisturizing Body Cleanser or THERATM Foaming Body Cleanser
  • Apply paste to area as needed
  • For G-tubes, cleanse as above, apply thin layer and secure with drain sponge or product as directed

Other information

  • Protect from freezing. Avoid excessive heat.

Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, SAFFLEXTM (Consisting of: Calcium Pantothenate (Vitamin B5), Maltodexdrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E)), Bisabolol, Carthamus Tinctorius (Safflower) Olesomes, Carthamus Tinctorius (Safflower) Seed Oil, Lavender Ylang Fragrance, Modified Corn Starch, Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate, Petrolatum, Phenoxyethanol, Sodium Hyaluronate, Zingiber Officinale (Ginger) Root Extract.

Label (4 oz)

image of 4 oz label

Label(4 g)

image of 4 g label

Carton

image of carton

THERA CALAZINC BODY SHIELD 
zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68599-0205
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
KUKUI NUT OIL 
ALOE VERA LEAF 
CALCIUM PANTOTHENATE 
MALTODEXTRIN 
NIACINAMIDE 
PYRIDOXINE HYDROCHLORIDE 
SILICON DIOXIDE 
SODIUM ASCORBYL PHOSPHATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
LEVOMENOL 
SAFFLOWER OIL 
PETROLATUM 
PHENOXYETHANOL 
HYALURONATE SODIUM 
GINGER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68599-0205-4113 g in 1 TUBE
2NDC:68599-0205-1144 in 1 CARTON
24 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/2011
Labeler - McKesson Medical-Surgical Inc. (023904428)
Registrant - PureTek Corporation (785961046)
Establishment
NameAddressID/FEIBusiness Operations
PureTek Corporation785961046manufacture, label, pack, outsourcing human drug compounding, relabel, repack

Revised: 9/2011
 
McKesson Medical-Surgical Inc.

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