Thera Plus Vitamin A and D Cream

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Thera Plus Vitamin A and D Cream
Generic name: DIMETHICONE, ZINC OXIDE
Manufacturer: FOURSTAR GROUP USA, INC.
Product type: HUMAN OTC DRUG
SPL set ID: 36f09fa4-a3b8-4104-9745-ee60aa493b06
SPL ID: 49d87e00-eec1-3209-e063-6294a90afc41
Version: 2
Effective date: 2026-02-02
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:27:02

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		Thera Plus Vitamin A and D Cream	openfda.brand_name
generic name		DIMETHICONE, ZINC OXIDE	openfda.generic_name
manufacturer name		FOURSTAR GROUP USA, INC.	openfda.manufacturer_name
ndc	package	80684-135-01	openfda.package_ndc
ndc	product	80684-135	openfda.product_ndc
ndc11	package	80684013501	derived:openfda.package_ndc
rxcui		686403	openfda.rxcui
spl id		49d87e00-eec1-3209-e063-6294a90afc41	id
spl set id		36f09fa4-a3b8-4104-9745-ee60aa493b06	set_id
unii		SOI2LOH54Z	openfda.unii
unii		92RU3N3Y1O	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Do not use over large areas of the body not for extensive burns or serious cuts, consult a physician When using this product avoid contact with eyes Ask a doctor before use serious burns deep wounds Stop use and ask a doctor if 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. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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