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:

Label2

THERAWORX PROTECT ADVANCED HYGIENE WITH SKIN PROTECTANT ALLANTOIN 4 COUNT WIPE
allantoin cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61594-040
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61594-040-00	4 in 1 CARTON	07/01/2024
1		18 g in 1 POUCH; Type 0: Not a Combination Product

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

Labeler - AVADIM HOLDINGS, INC. (118512488)

Theraworx Protect Advanced Hygiene with Skin Protectant Allantoin 4 Count Wipe