DIAPER RASH CREAM- zinc oxide cream 
Hamilton Therapeutics, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Diaper Rash Cream

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

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

Stop use and ask adoctor if

• condition worsens

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

WarningsFor external use only.

When using this product • Avoid contact with eyes

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 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.

Diaper Rash Cream

3.3 FL OZ / 98mL

Diaper Rash Cream

DIAPER RASH CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72381-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCONUT OIL (UNII: Q9L0O73W7L)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72381-101-0198 mL in 1 TUBE; Type 0: Not a Combination Product06/07/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/07/2018
Labeler - Hamilton Therapeutics, Inc (099419360)

Revised: 11/2022
Document Id: eeb638e4-3f9a-bc42-e053-2a95a90ae06a
Set id: 6e111e75-5612-69c8-e053-2a91aa0abfa8
Version: 5
Effective Time: 20221130
 
Hamilton Therapeutics, Inc