Theraworx Patented Foam Formulation

Theraworx Patented Foam Formulation

Drug Labeling and Warnings

Drug Details

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THERAWORX PATENTED FOAM FORMULATION  - allantoin liquid 
Avadim Technologies, 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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 61594-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61594-001-0050 mL in 1 BOTTLE
2NDC: 61594-001-01109 mL in 1 BOTTLE
3NDC: 61594-001-02210 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/09/2014
Labeler - Avadim Technologies, Inc. (041443877)
Establishment
NameAddressID/FEIBusiness Operations
Avadim Technologies, Inc.041443877manufacture(61594-001)

Revised: 1/2014
 
Avadim Technologies, Inc.


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