Theraworx Protect Advanced Hygiene with Skin Protectant Fragrance Free

Theraworx Protect Advanced Hygiene with Skin Protectant Fragrance Free by

Drug Labeling and Warnings

Theraworx Protect Advanced Hygiene with Skin Protectant Fragrance Free by is a Otc medication manufactured, distributed, or labeled by AVADIM HOLDINGS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

THERAWORX PROTECT ADVANCED HYGIENE WITH SKIN PROTECTANT FRAGRANCE FREE- allantoin cloth 
AVADIM HOLDINGS, INC.

----------

Theraworx Protect Advanced Hygiene with Skin Protectant Fragrance Free

Drug Facts

Active Ingredient

Allantoin 0.65%

Purpose

Skin Protectant

Uses

•  temporarily protects minor:
• cuts 
• scrapes
• burns
• temporarily protects chapped or cracked skin

Warnings

For external use only

Do not use

• on puncture wounds
• on animal bites
• on serious burns

When using this product

• do not get into eyes

Stop use and ask  a doctor if:

• condition worsens 
• symptoms last more then 7 days or clear up and occur again within a few days

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Directions

• apply as needed

Other Information

• store between 32ºF and 120ºF
• do not use if seal is broken

Inactive Ingredients

(Alphabetical) Aloe barbadensis Leaf Extract, Aloe barbadensis Leaf juice, Aqua (water), Citrus Grandis (Grapefruit) seed Extract, Cocamidopropyl Betaine, Colloidal Silver, Glycerin, Lauryl Glucoside, Methylparaben, Parfum (Fragrance), PEG/PPG-4/12 Dimethicone, Propylparaben, Tetrasodium EDTA,Tocopheryl Acetate (Vitamin E), Yeast Extract

Package Labeling:

THERAWORX PROTECT ADVANCED HYGIENE WITH SKIN PROTECTANT FRAGRANCE FREE 
allantoin cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61594-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	6.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GRAPEFRUIT (UNII: O82C39RR8C)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SILVER (UNII: 3M4G523W1G)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61594-037-00	8 in 1 CARTON	07/01/2024	07/01/2024
1		18 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/01/2024	07/01/2024

Labeler - AVADIM HOLDINGS, INC. (118512488)

Revised: 10/2024

Document Id: 254f27b1-cb43-94a3-e063-6394a90a5bf0

34390-5

Set id: 0f8d3c7f-3e10-b98d-e063-6294a90a911f

Version: 2

Effective Time: 20241025