FDA.reportPublic FDA data

United Spirit of America

Manufacturer
Prime Enterprises, Inc.
Effective date
2021-08-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:30:10

Label at a glance#

ProductUnited Spirit of America Anti Perspirant Deodorant
Active ingredientALUMINUM CHLOROHYDRATE
Label structure7 sections

Indications and uses

Decreases underarm perspiration.

Dosage and administration

Directions Apply to underarms only

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Aluminum Chlorohydrate 25%

Purpose

OTC - PURPOSE SECTION

Antiperspirant

Uses

INDICATIONS & USAGE SECTION

Decreases underarm perspiration.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on broken skin.

OTC - STOP USE SECTION

Stop use if rash or irritation occurs.

OTC - ASK DOCTOR SECTION

Ask a doctor before useif you have kidney disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Other Information

SPL UNCLASSIFIED SECTION

Other Information Do not store above 115°F.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions Apply to underarms only

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetyl Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Diazolidinyl Urea, Fragrance, Glycerin, Glyceryl Stearate, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Propylparaben, SD Alcohol 40-B, Tetrasodium EDTA, Water, Xanthan Gum

PRINCIPAL DISPLAY PANEL - 89 mL Roll On Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-041458443-0414-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
CYCLOMETHICONE 6XHK3U310BAIACT
METHYLPARABENA2I8C7HI9TIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE SODIUM TETRAHYDRATEL13NHD21X6IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PEG-100 STEARATEYD01N1999RIACT
ALUMINUM CHLOROHYDRATEHPN8MZW13MACTIB
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
CYCLOMETHICONE 50THT5PCI0RIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ca8eb97a-b04b-4639-e053-2995a90a6ca4ca8e9f8e-6c35-3bad-e053-2a95a90ae7b52021-08-27WarningsExact identifier
spl id: ca8eb97a-b04b-4639-e053-2995a90a6ca4
spl set id: ca8e9f8e-6c35-3bad-e053-2a95a90ae7b5

Reported adverse events (FAERS/openFDA)#

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