SWEET CHEEKS DIAPER- zinc oxide paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Zinc Oxide 14%

Available from:

Tubby Todd

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

SWEET CHEEKS DIAPER- ZINC OXIDE PASTE
TUBBY TODD
_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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TUBBY TODD - SWEET CHEEKS DIAPER PASTE (73088-301)
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
SWEET CHEEKS DIAPER
zinc oxide paste
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:73088-301
Tubby Todd
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
ZINC CATION
100 g in 14 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
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)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
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 INFORMATION
MARKETING