FDA.reportPublic FDA data

Theraworx Protect Advanced Hygiene

Manufacturer
AVADIM HOLDINGS, INC.
Effective date
2024-01-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:59:50

Label at a glance#

ProductTheraworx Protect Advanced Hygiene
Active ingredientALLANTOIN
Label structure7 sections

Indications and uses

temporarily protects minor: cuts  scrapes burns  temporarily protects chapped or cracked skin

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.65%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects minor:
  • cuts 
  • scrapes
  • burns 
  • temporarily protects chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on puncture wounds
  • on animal bites
  • on serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor

OTC - STOP USE SECTION

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

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply as needed

Other Information

SPL UNCLASSIFIED SECTION

  • store between 32°F and 120°F
  • do not use if seal is broken

Inactive Ingredients (Alphabetical)

INACTIVE INGREDIENT SECTION

Aloe barbadensis Leaf Extract, Aloe barbadensis Leaf Juice, Aqua (Water), Citrus Grandis (Grapefruit) Seed Extract, Cocamidopropyl Betaine, Colloidal Silver, Glycerin, Lauryl Glucoside, Methylparaben, Parfum (Fragrance), PEG/PPG-4/12 Dimethicone, Propylparaben, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Yeast Extract

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61594-03561594-035-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CITRUS MAXIMA SEED083X55C543IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SILVER3M4G523W1GIACT
GLYCERINPDC6A3C0OXIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
METHYLPARABENA2I8C7HI9TIACT
PEG/PPG-4/12 DIMETHICONEJAN3585W85IACT
PROPYLPARABENZ8IX2SC1OHIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
ALLANTOIN344S277G0ZACTIB

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
254f25ac-0267-c2e8-e063-6394a90a11d50f280b86-aa2f-6511-e063-6394a90a283f2024-10-25WarningsExact identifier
spl set id: 0f280b86-aa2f-6511-e063-6394a90a283f

Reported adverse events (FAERS/openFDA)#

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