THERA CALAZINC BODY SHIELD- zinc oxide paste

THERA Calazinc Body Shield by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 THERA TM Moisturizing Body Cleanser or THERA TM 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.

INACTIVE INGREDIENT

• Aleurites Moluccana Seed Oil,
• Aloe Barbadensis (Aloe Vera) Leaf Juice,
• SAFFLEX TM (Consisting of: Calcium Pantothenate (Vitamin B 5),
• Maltodexdrin,
• Niacinamide (Vitamin B 3),
• Pyridoxine HCl (Vitamin B 6),
• 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)

NDC: 68599-0205-4

Thera

Calazinc Body Shield

Net Contents 4 fl oz (118 mL)

MFR# 53-CZ4

Label(4 g)

NDC: 68599-0205-1

Thera

Calazinc Body Shield

Net Weight 4 g (0.14 oz)

MFR# 53-CZ4G

Box

NDC: 68599-0205-1

Thera

Calazinc Body Shield

Net Weight 4 g (0.14 oz)

MFR# 53-CZ4G

INGREDIENTS AND APPEARANCE

THERA CALAZINC BODY SHIELD 
zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

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)
SAFFLOWER OIL (UNII: 65UEH262IS)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0205-4	113 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2011
2	NDC: 68599-0205-1	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)