Label: THERA CALAZINC BODY SHIELD - zinc oxide paste
- NDC Code(s): 68599-0205-1, 68599-0205-4
- Packager: McKesson Medical-Surgical Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
Zinc Oxide 20.0% (3.0% as Calamine)
Skin Protectant Close
- Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- For the treatment and/or prevention of diaper rash
- temporarily protects and helps relieve minor skin irritation and itching due to rashes
For external use only
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
- condition worsens
- 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.
- 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. Close
- Label (4 oz)
- Label(4 g)
- INGREDIENTS AND APPEARANCE
THERA CALAZINC BODY SHIELD
zinc oxide paste
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68599-0205 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-0205-4 113 g in 1 TUBE 2 NDC:68599-0205-1 144 in 1 CARTON 2 4 g 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