Thera Plus Vitamin A and D Cream

Manufacturer: FOURSTAR GROUP USA, INC.
Effective date: 2026-02-02
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:36:09

Label at a glance#

ProductThera Plus Vitamin A and D Cream

Active ingredientDIMETHICONE, ZINC OXIDE

Label structure8 sections

Indications and uses

helps prevent diaper rash heals dry, flaky and chafed skin soothes and protects minor cuts and burns

Dosage and administration

Adults and children 2 years of age and older: apply generously and massage until absorbed. Repeat as necessary children under 2 years of age: ask a doctor before use

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-639-3803

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%
Zinc oxide 10%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

helps prevent diaper rash
heals dry, flaky and chafed skin
soothes and protects minor cuts and burns

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

over large areas of the body
not for extensive burns or serious cuts, consult a physician

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Ask a doctor before use

OTC - ASK DOCTOR SECTION

serious burns
deep wounds

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms last for more than 7 days
redness, irritation, swelling or pain persists or increases or if infection develops.
symptoms clear up and then occur again within a few days

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: apply generously and massage until absorbed. Repeat as necessary
children under 2 years of age: ask a doctor before use

Other information

SPL UNCLASSIFIED SECTION

store at room temperature 68° - 72°F (20° - 22°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

cod liver oil, vitamin E, white petrolatum

Questions?

OTC - QUESTIONS SECTION

1-800-639-3803Weekdays 9 AM to 4 PM EST

Package Label:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
686403	dimethicone 1 % / zinc oxide 10 % Topical Cream	PSN	2
686403	dimethicone 10 MG/ML / zinc oxide 100 MG/ML Topical Cream	SCD	2
686403	dimethicone 1 % / zinc oxide 10 % Topical Cream	SY	2
686403	dimethicone 10 MG/ML / ZNO 100 MG/ML Topical Cream	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0049696700405	GTIN-13: 0049696700405 EAN-13: 0049696700405 GTIN-12: 049696700405 UPC-A: 049696700405 GTIN storage (14 digits): 00049696700405	Label0.jpg

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
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80684-135-01	Thera Plus Vitamin A and D Cream	42.5 g in 1 TUBE	CREAM	42.5		2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Thera Plus Vitamin A and D Cream
DIMETHICONE, ZINC OXIDE
COD LIVER OIL
.ALPHA.-TOCOPHEROL
WHITE PETROLATUM
DIMETHICONE
ZINC OXIDE
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80684-135	80684-135-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COD LIVER OIL	BBL281NWFG	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
WHITE PETROLATUM	B6E5W8RQJ4	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIM

Source Document#

Source XML

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 Plus Vitamin A and D Cream	DIMETHICONE, ZINC OXIDE	FOURSTAR GROUP USA, INC.	36f09fa4-a3b8-4104-9745-ee60aa493b06	2026-02-02	Warnings	Exact identifier ndc (package): 80684-135-01 ndc (product): 80684-135 ndc11 (package): 80684013501 spl id: 49d87e00-eec1-3209-e063-6294a90afc41 spl set id: 36f09fa4-a3b8-4104-9745-ee60aa493b06

Reported adverse events (FAERS/openFDA)#

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