THERA Calazinc Body Shield

Manufacturer: McKesson Medical-Surgical Inc. | Central Solutions
Effective date: 2024-06-17
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:13:50

Label at a glance#

ProductTHERA Calazinc Body Shield

Active ingredientZINC OXIDE

Label structure10 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

Protect from freezing. Avoid excessive heat.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.0% (3.0% as Calamine)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

deep or puncture wounds
animal bites
serious burns

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

Protect from freezing. Avoid excessive heat.

INACTIVE INGREDIENT SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-0205-4

Thera

Calazinc Body Shield

Net Contents 4 fl oz (113 mL)

MFR# 53-CZ4

each

Label(4 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-0205-1

Thera

Calazinc Body Shield

Net Weight 4 g (0.14 oz)

MFR# 53-CZ4G

box

each

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68599-0205-1	THERA Calazinc Body Shield	144 in 1 CARTON	PASTE	144	5
68599-0205-1	THERA Calazinc Body Shield	4 g in 1 PACKET	PASTE	4	5
68599-0205-4	THERA Calazinc Body Shield	113 g in 1 TUBE	PASTE	113	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68599-0205	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	5	Current NDC, Legacy NDC, 3 package rows	20240619_974b1046-83ee-4207-91d3-40982beb9c63.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	1
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
CALCIUM PANTOTHENATE	INACTIVE INGREDIENT	568ET80C3D	1
GINGER	INACTIVE INGREDIENT	C5529G5JPQ	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	1
KUKUI NUT OIL	INACTIVE INGREDIENT	TP11QR7B8R	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	1
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

THERA Calazinc Body Shield
Zinc Oxide
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 CARBONATE
ZINC CATION
THREONINE
GLUTAMIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68599-0205	68599-0205-4, 68599-0205-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HISTIDINE	4QD397987E	IACT
TYROSINE	42HK56048U	IACT
LYSINE	K3Z4F929H6	IACT
ISOLEUCINE	04Y7590D77	IACT
KUKUI NUT OIL	TP11QR7B8R	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
CALCIUM PANTOTHENATE	568ET80C3D	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
NIACINAMIDE	25X51I8RD4	IACT
PYRIDOXINE HYDROCHLORIDE	68Y4CF58BV	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT
LEVOMENOL	24WE03BX2T	IACT
SAFFLOWER OIL	65UEH262IS	IACT
PETROLATUM	4T6H12BN9U	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
GINGER	C5529G5JPQ	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB
ASPARTIC ACID	30KYC7MIAI	IACT
ALANINE	OF5P57N2ZX	IACT
PROLINE	9DLQ4CIU6V	IACT
MINERAL OIL	T5L8T28FGP	IACT
VALINE	HG18B9YRS7	IACT
WATER	059QF0KO0R	IACT
SERINE	452VLY9402	IACT
CHLORPHENESIN	I670DAL4SZ	IACT
OCTENYLSUCCINIC ACID	12UZE4X73L	IACT
GLYCINE	TE7660XO1C	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
CARTHAMUS TINCTORIUS SEED OLEOSOMES	9S60Q72309	IACT
PHENYLALANINE	47E5O17Y3R	IACT
ZEA MAYS WHOLE	1G5HNE09V8	IACT
LEUCINE	GMW67QNF9C	IACT
ARGININE	94ZLA3W45F	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
ZINC CARBONATE	EQR32Y7H0M	IACT
THREONINE	2ZD004190S	IACT
GLUTAMIC ACID	3KX376GY7L	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 81 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	PASTE / ORAL		1050 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route 27 equally ranked IID candidates
GINGER	GINGER	C5529G5JPQ	SYRUP / ORAL	0.05 ml/5ml		Exact identifier — unii candidate 6 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	PASTE / ORAL		1050 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	CREAM / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii+dosage form 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii+route 18 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii+dosage form 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii+route 18 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	GEL / TOPICAL		25 mg	Exact identifier — unii+route 6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	OINTMENT / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
GINGER	GINGER	C5529G5JPQ	ELIXIR / ORAL	10 mg/5ml		Exact identifier — unii candidate 6 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii+route 18 equally ranked IID candidates
GINGER	GINGER	C5529G5JPQ	SYRUP / ORAL	0.05 ml/5ml		Exact identifier — unii candidate 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
SAFFLOWER OIL	SAFFLOWER OIL	65UEH262IS	LOTION / TOPICAL		3510 mg	Exact identifier — unii+route 3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	AEROSOL, FOAM / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	PASTE / ORAL		1050 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
SAFFLOWER OIL	SAFFLOWER OIL	65UEH262IS	LOTION / TOPICAL		3510 mg	Exact identifier — unii+route 3 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
GINGER	GINGER	C5529G5JPQ	ELIXIR / ORAL	10 mg/5ml		Exact identifier — unii candidate 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii+dosage form 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route 6 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	GEL / TOPICAL		463 mg	Exact identifier — unii+route 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
SAFFLOWER OIL	SAFFLOWER OIL	65UEH262IS	LOTION / TOPICAL		3510 mg	Exact identifier — unii+route 3 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	CREAM / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route 6 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	GEL / TOPICAL		25 mg	Exact identifier — unii+route 6 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	CREAM / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route 27 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THERA Calazinc Body Shield	ZINC OXIDE	McKesson Medical-Surgical Inc.	974b1046-83ee-4207-91d3-40982beb9c63	2024-06-17	Warnings	Exact identifier ndc (package): 68599-0205-4 ndc (package): 68599-0205-1 ndc (product): 68599-0205 ndc11 (package): 68599020504 ndc11 (package): 68599020501 spl id: 1b1bf6ec-a0cf-df7a-e063-6394a90af9f6 spl set id: 974b1046-83ee-4207-91d3-40982beb9c63

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.