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NDC 73088-0301-18 Sweet Cheeks Diaper 100 g/14mL Details

Sweet Cheeks Diaper 100 g/14mL

Sweet Cheeks Diaper is a TOPICAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by Tubby Todd. The primary component is ZINC OXIDE.

Product Information

NDC	73088-0301
Product ID	73088-301_da33a6ff-92ee-942f-e053-2995a90aa0db
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Sweet Cheeks Diaper
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	g/14mL
Substance Name	ZINC OXIDE
Labeler Name	Tubby Todd
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 73088-0301-18 (73088030118)

Pricing Information	N/A
NDC Package Code	73088-301-18
Billing NDC	73088030118
Package	224 mL in 1 TUBE (73088-301-18)
Marketing Start Date	2021-04-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4ed0afe1-c893-453e-b4d5-f32561360ec1 Details

Active Ingredients

Zinc Oxide 14%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash
Protects chaftes skin due to diaper rash and helps seal out wetness

Warnings

For External Use Only

When using this product do not use near eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if condition worsens. Symptoms may last more than 7 days.
Keep out of reach of children. If swollowed, seek medical advice or contact a Poison Control Center immediately.

Inactive ingredients

Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Cera Alba (Beeswax), Cocos Nuciffera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Oil, Butyrospermum Parkii (Shea) Butter, Tocopherol

Tubby Todd Sweet Cheeks Diaper Paste

INGREDIENTS AND APPEARANCE

SWEET CHEEKS DIAPER

zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73088-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 g in 14 mL

Ingredient Name	Strength
Inactive Ingredients
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73088-301-18	224 mL in 1 TUBE; Type 0: Not a Combination Product	04/20/2021
2	NDC:73088-301-14	114 mL in 1 TUBE; Type 0: Not a Combination Product	04/20/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/20/2021

Labeler - Tubby Todd (052545299)

Revised: 3/2022

Document Id: da33a6ff-92ee-942f-e053-2995a90aa0db

Set id: 4ed0afe1-c893-453e-b4d5-f32561360ec1

Version: 5

Effective Time: 20220314