THERAWORX PATENTED FOAM FORMULATION- allantoin liquid
Avadim Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Foam

THERAWORX PATENTED FOAM FORMULATION
allantoin liquid

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SILVER (UNII: 3M4G523W1G)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETIC ACID (UNII: 9G34HU7RV0)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61594-001-00	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2014	03/31/2017
2	NDC:61594-001-01	109 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2014	03/31/2017
3	NDC:61594-001-02	210 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2014	03/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/09/2014	03/31/2017

Labeler - Avadim Health, Inc. (041443877)

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

Revised: 9/2021

Document Id: cd121590-98cf-5042-e053-2a95a90a8241

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

Version: 3

Effective Time: 20210928

Avadim Health, Inc.