Theraworx Protect Advanced Hygiene with Skin Protectant

Theraworx Protect Advanced Hygiene with Skin Protectant by

Drug Labeling and Warnings

Theraworx Protect Advanced Hygiene with Skin Protectant 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- allantoin cloth 
AVADIM HOLDINGS, INC.

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Theraworx Protect Advanced Hygiene with Skin Protectant

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 32 F and 120 F
• 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 
allantoin cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61594-036
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GRAPEFRUIT (UNII: O82C39RR8C)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SILVER (UNII: 3M4G523W1G)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 61594-036-00	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: 254f1827-6088-191e-e063-6394a90ab30f

34390-5

Set id: 0f8d3b85-19b0-72c1-e063-6394a90a18c7

Version: 2

Effective Time: 20241025