Theraworx Patented Foam Formulation

Dosage form: liquid
Ingredients: ALLANTOIN 5mg in 1mL
Labeler: Avadim Health, Inc.
NDC code: 61594-001

Medically reviewed by Drugs.com. Last updated on Nov 19, 2024.

Theraworx Patented Foam Formulation

Active Ingredient:

Allantoin 0.5%

Purpose

Skin Protectant

Uses:

For temporary Protection of minor cuts, scrapes, burns, and chapped or cracked skin.

Warning:

For external use only.

Keep out of reach of children.

Do not use in the eyes.

Do not use on deep or puncture wounds, animal bites, or serious burns.
Extended use may increase risk of sunburn.

Stop use and ask doctor

if condition worsens or symptoms last more than seven days.

Directions:

Dispense foam onto cloth.
Apply to desired area.
No rinse needed.

Inactive Ingredients:

Purified Water, Aloe, Citrus Based Preservative, Cocamidopropyl Betaine, Colloidal Silver, Lauryl Glucoside, Beta Glucan, Dimethicone, Methyl Paraben, Propyl Paraben, EDTA, Fragrance, Vitamin E

Theraworx Patented Foam Formulation 50ml (61594-001-00) | Theraworx Patented Foam Formulation 109ml (61594-001-01) | Theraworx Patented Foam Formulation 210ml (61594-001-02)

Representative Labeling

THERAWORX PATENTED FOAM FORMULATION
allantoin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61594-001
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (ALLANTOIN)	ALLANTOIN	5 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
ALOE
COCAMIDOPROPYL BETAINE
SILVER
LAURYL GLUCOSIDE
DIMETHICONE
METHYLPARABEN
PROPYLPARABEN
EDETIC ACID
.ALPHA.-TOCOPHEROL

Packaging
#	Item Code	Package Description
1	NDC:61594-001-00	50 mL in 1 BOTTLE
2	NDC:61594-001-01	109 mL in 1 BOTTLE
3	NDC:61594-001-02	210 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/09/2014

Labeler - Avadim Health, Inc. (041443877)

Establishment
Name	Address	ID/FEI	Operations
Avadim Health, Inc.		041443877	manufacture(61594-001)

Revised: 11/2019

Document Id: 987ce265-6948-5f26-e053-2a95a90a468a

Set id: c06dc492-a9cc-485a-ae15-b4cd8fef50dc

Version: 2

Effective Time: 20191129

Avadim Health, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Theraworx Patented Foam Formulation

Further information

See also:

Qulipta

Aimovig

Dupixent

Ubrelvy

Nurtec ODT

Xeomin

Dysport

Botox Cosmetic

Arazlo

Tazorac