DIAPER RASH CREAM- zinc oxide cream

Diaper Rash Cream by

Drug Labeling and Warnings

Diaper Rash Cream by is a Otc medication manufactured, distributed, or labeled by Hamilton Therapeutics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose
Zinc Oxide 15% ..................................... Skin Protectant

PURPOSE

Uses Helps treat and prevent diaper rash. Protects
chafed skin due to diaper rash and helps seal out wetness.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask adoctor if

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days.

WARNINGS

WarningsFor external use only.

When using this product Avoid contact with eyes

DOSAGE & ADMINISTRATION

Directions

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

INACTIVE INGREDIENT

Inactive ingredients Helianthus Annuus (Sunflower) Seed Oil, Beeswax (Cera Alba), Polyhydroxystearic Acid, Butyrospermum Parkii (Shea Butter), Calophyllum Tacamahaca (Tamanu) Seed Oil, Olea Europaea (Olive) Fruit Oil, Cocos Nucifera (Coconut) Oil, Honey, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract,Tocopherol, Squalene, Sterols, Monoglycerides.

PRINCIPAL DISPLAY PANEL

Diaper Rash Cream

3.3 FL OZ / 98mL

INGREDIENTS AND APPEARANCE

DIAPER RASH CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72381-101
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 mL

Inactive Ingredients
Ingredient Name	Strength
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)
OLIVE OIL (UNII: 6UYK2W1W1E)
HONEY (UNII: Y9H1V576FH)
LEMON PEEL (UNII: 72O054U628)
SAGE (UNII: 065C5D077J)
SQUALENE (UNII: 7QWM220FJH)
WHITE WAX (UNII: 7G1J5DA97F)
CHAMOMILE (UNII: FGL3685T2X)
CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)
CITRUS SINENSIS FLOWER (UNII: H02N5LQ5F6)
THYME (UNII: CW657OBU4N)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72381-101-01	98 mL in 1 TUBE; Type 0: Not a Combination Product	06/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/07/2018

Labeler - Hamilton Therapeutics, Inc (099419360)

Establishment
Name	Address	ID/FEI	Business Operations
VEGE-KURL, INC.		021072509	manufacture(72381-101)