OTC Medication Information: Diaper Rash Cream

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.

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.

Warnings For 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
(click image for full-size original)
DIAPER RASH CREAM
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72381-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
SUNFLOWER OIL
POLYHYDROXYSTEARIC ACID (2300 MW)
SHEA BUTTER
COCONUT OIL
CALOPHYLLUM TACAMAHACA SEED OIL
OLIVE OIL
HONEY
LEMON PEEL
SAGE
SQUALENE
WHITE WAX
CHAMOMILE
CITRUS AURANTIUM FLOWER
CITRUS SINENSIS FLOWER
THYME
TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72381-101-01 98 mL in 1 TUBE None
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)

Revised: 11/2022 Hamilton Therapeutics, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.