DIAPER RASH CREAM- zinc oxide cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:

Zinc Oxide 15% Purpose Skin protectant

PURPOSE

Uses: Helps prevent irritation

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warning:

• For external use only. When using this product keep out of eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION

Directions: After changing diaper allow the area to dry. then apply diaper rash cream liberally to affected areas.

INACTIVE INGREDIENT

Water, Caprylic/Capric Triglyceride, Glycerin. C13-15 Alkane, Ethylhexyl Olivate, Propanediol, Polyglyceryl-3 Polyricinoleate, Bis-Octyldodecylhexyl Dimer Dilinoleate/Propanediol Copolymer, Cocoglycerides, Meadowfoam Estolide, Disteardimonium Hectorite, Jojoba Esters, Hydrogenated Castor Oil, Lactococcus Ferment Lysate, Rhus Verniciflua Peel Wax, Squalane, 1,2-Hexanediol, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Linoleic Acid, Betaine, Sucrose, Hydroxyacetophenone, Phospholipids, Phytosterols, Sodium Citrate, Hydrolyzed Rhodophyceae Extract, Bisabolol, Panthenol, Sodium Dehydroacetate, Stearyl Glycyrrhetinate, Tocopherol, Tetrasodium Glutamate Diacetate, Linolenic Acid, Avena Sativa (Oat) Kernel Extract.

PRINCIPAL DISPLAY PANEL

Diaper Rash Cream

alleviate + soothe

Net Wt oz 85g

INGREDIENTS AND APPEARANCE

DIAPER RASH CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83369-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
C13-15 ALKANE (UNII: 114P5I43UJ)
ETHYLHEXYL OLIVATE (UNII: HTC7G3S2PV)
PANTHENOL (UNII: WV9CM0O67Z)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
SQUALANE (UNII: GW89575KF9)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
PYRUS MALUS (APPLE) FRUIT (UNII: B423VGH5S9)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
LINOLENIC ACID (UNII: 0RBV727H71)
LEVOMENOL (UNII: 24WE03BX2T)
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PROPANEDIOL (UNII: 5965N8W85T)
MEADOWFOAM ESTOLIDE (UNII: 3HH93SL2H9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
RHUS VERNICIFLUA PEEL WAX (UNII: 6RG2461FCH)
GLYCERIN (UNII: PDC6A3C0OX)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
TOCOPHEROL (UNII: R0ZB2556P8)
OAT (UNII: Z6J799EAJK)
SHEA BUTTER (UNII: K49155WL9Y)
BETAINE (UNII: 3SCV180C9W)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SUCROSE (UNII: C151H8M554)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LINOLEIC ACID (UNII: 9KJL21T0QJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83369-002-01	85 g in 1 CARTON; Type 0: Not a Combination Product	02/27/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/27/2026

Labeler - Smalls Brand LLC DBA Roe Wellness (058449263)