THERAWORX PRE-MOISTENED CLOTHS- 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 pre-moistened cloths

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:

Cleanse with either side of the cloth allowing skin to air dry. No rinse needed. DO NOT FLUSH

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 pre-moistened cloths 2 count (61594-000-00)| Theraworx pre-moistened cloths 8 count (61594-000-01)

Representative Labeling

Cloth Front

Cloth Back

THERAWORX PRE-MOISTENED CLOTHS
allantoin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61594-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g in 100 g

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:61594-000-00	35 g in 1 POUCH; Type 0: Not a Combination Product	03/13/2014	03/31/2017
2	NDC:61594-000-01	140 g in 1 POUCH; Type 0: Not a Combination Product	03/13/2014	03/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/13/2014	03/31/2017

Labeler - AVADIM HEALTH, INC. (033039605)

Name	Address	ID/FEI	Business Operations
Establishment
AVADIM HEALTH, INC		033039605	manufacture(61594-000)

Revised: 1/2023

Document Id: f2737da0-a8f2-ebf7-e053-2995a90aef2a

Set id: e7e8db77-1c0a-4313-9f53-24dca617a4db

Version: 5

Effective Time: 20230117

AVADIM HEALTH, INC.