Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 974b1046-83ee-4207-91d3-40982beb9c63
Route
TOPICAL
Published
Effective Date 2011-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Histidine Tyrosine Lysine Isoleucine Kukui Nut Oil Aloe Vera Leaf Calcium Pantothenate Maltodextrin Niacinamide Pyridoxine Hydrochloride Silicon Dioxide .alpha.-tocopherol Acetate, Dl- Levomenol Safflower Oil Petrolatum Hyaluronate Sodium Ginger Aspartic Acid Alanine Proline Mineral Oil Valine Water Serine Chlorphenesin Octenylsuccinic Acid Glycine Caprylyl Glycol Carthamus Tinctorius Seed Oleosomes Phenylalanine Zea Mays Whole Leucine Arginine Butylene Glycol Zinc Cation Threonine Glutamic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-09-01
Description

Zinc Oxide 20.0% (3.0% as Calamine)

Purpose

Skin Protectant

Medication Information

Purpose
  • Skin Protectant
Description

Zinc Oxide 20.0% (3.0% as Calamine)

Uses



  • For the treatment and/or prevention of diaper rash
  • temporarily protects and helps relieve minor skin irritation and itching due to rashes

Section 51727-6
  • 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.
Warnings
  • For external use only

Directions



  • Cleanse skin with THERA TMMoisturizing Body Cleanser or THERA TMFoaming 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

Label(4 G)

NDC 68599-0205-1

Thera

Calazinc Body Shield

Net Weight 4 g (0.14 oz)

MFR# 53-CZ4G

Label (4 Oz)

NDC 68599-0205-4

Thera

Calazinc Body Shield

Net Contents 4 fl oz (113 mL)

MFR# 53-CZ4

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient
  • Zinc Oxide 20.0% (3.0% as Calamine)

Other Information
  • Protect from freezing. Avoid excessive heat.
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
Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses



  • For the treatment and/or prevention of diaper rash
  • temporarily protects and helps relieve minor skin irritation and itching due to rashes

Section 51727-6 (51727-6)
  • 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.
Purpose
  • Skin Protectant
Warnings
  • For external use only

Directions



  • Cleanse skin with THERA TMMoisturizing Body Cleanser or THERA TMFoaming 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

Label(4 G) (Label(4 g))

NDC 68599-0205-1

Thera

Calazinc Body Shield

Net Weight 4 g (0.14 oz)

MFR# 53-CZ4G

Label (4 Oz) (Label (4 oz))

NDC 68599-0205-4

Thera

Calazinc Body Shield

Net Contents 4 fl oz (113 mL)

MFR# 53-CZ4

Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient (Active ingredient)
  • Zinc Oxide 20.0% (3.0% as Calamine)

Other Information (Other information)
  • Protect from freezing. Avoid excessive heat.
When Using This Product (When using this product)
  • do not get into eyes
Stop Use and Ask A Doctor If (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
Keep Out of Reach of Children. (Keep out of reach of children.)
  • If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:10.388968 · Updated: 2026-03-14T23:03:06.131630