TRIDERMA STUBBORN DIAPER RASH RELIEF- allantoin cream cream

TriDerma Stubborn Diaper Rash Relief by

Drug Labeling and Warnings

TriDerma Stubborn Diaper Rash Relief by is a Otc medication manufactured, distributed, or labeled by Genuine Virgin Aloe Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Allantoin 1.5%

Purpose

Skin Protectant

INDICATIONS & USAGE

• Helps treat and prevent diaper rash
• Helps seal out wetness
• Temporarily protects and helps relieve chafed, chapped or cracked skin

WARNINGS

For external use only

Do not use on

• deep or puncture wounds
• on infections
• on lacerations

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

if condition worsens or does not improve within 7 days

if swallowed get medical help or contact a Poison Control Center right away.

Questions: 1-800-279-7282 M-F 8 am-4pm PST

STORAGE AND HANDLING

• Store at room temperature
• for use on infants or children

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice*,
Avena Sativa (Oat) Kernel Flour, Cera Alba (Beeswax),
Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Cetyl
Alcohol, Dimethicone, Ethylhexylglycerin, Glyceryl Stearate,
Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed
Oil, Isopropyl Palmitate, Panthenol (Pro-Vitamin B5),
Phenoxyethanol, Polysorbate 60, Potassium Cetyl
Phosphate, Propanediol, Sodium Hyaluronate, Sodium
Hydroxide, Sodium PCA, Sodium Phytate, Tocopheryl
Acetate (Vitamin E), Water (Aqua), Xanthan Gum, Zinc PCA.

DOSAGE & ADMINISTRATION

Change wet/soiled diapers promptly. Cleanse diaper area and allow to dry. Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIDERMA STUBBORN DIAPER RASH RELIEF 
allantoin cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-168
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
SODIUM PCA (UNII: 469OTG57A2)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
SODIUM PHYTATE (UNII: 88496G1ERL)
BEESWAX (UNII: 2ZA36H0S2V)
CETYL ALCOHOL (UNII: 936JST6JCN)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
AVENA SATIVA (OAT) STARCH (UNII: 904CE6697V)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
DIMETHICONE 100 (UNII: RO266O364U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPANEDIOL (UNII: 5965N8W85T)
ZINC PCA (UNII: C32PQ86DH4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10738-168-40	1 in 1 CARTON	01/01/2025
1	NDC: 10738-168-45	113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/01/2025

Labeler - Genuine Virgin Aloe Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-168)