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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 21, 2022.

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

THERAWORX PATENTED FOAM FORMULATION 
allantoin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALOE 
COCAMIDOPROPYL BETAINE 
SILVER 
LAURYL GLUCOSIDE 
DIMETHICONE 
METHYLPARABEN 
PROPYLPARABEN 
EDETIC ACID 
.ALPHA.-TOCOPHEROL 
Packaging
#Item CodePackage Description
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 Health, Inc. (041443877)
Establishment
NameAddressID/FEIOperations
Avadim Health, Inc.041443877manufacture(61594-001)

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