THERAWORX PATENTED FOAM FORMULATION- allantoin liquid

Theraworx Patented Foam Formulation by

Drug Labeling and Warnings

Theraworx Patented Foam Formulation by is a Otc medication manufactured, distributed, or labeled by Avadim Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

THERAWORX PATENTED FOAM FORMULATION 
allantoin liquid

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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	Business Operations
Avadim Health, Inc.		041443877	manufacture(61594-001)