Butt Butter (Zinc Oxide) Ointment [Littles Skin Care, Incorporated] -

BUTT BUTTER (ZINC OXIDE) OINTMENT [LITTLES SKIN CARE, INCORPORATED]
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NDC	71976-101-01
Set ID	61ba725b-adfa-5ba5-e053-2991aa0ad451
Category	HUMAN OTC DRUG LABEL
Packager	Littles Skin Care, Incorporated
Generic Name
Product Class
Product Number
Application Number	PART347

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INACTIVE INGREDIENT

Avocado oil, cocoa-butter, shea butter, bees wax, castor oil, cod liver oil, coconut oil, wheat germ oil, lanolin, almond oil, grape seed oil, mixed tocopherol, lavender

Zinc Oxide
WARNINGS

For External Use only. Keep it away from childern.Avoid contact with eyes. If swallowed or If the condition worsen, contact a physician.
INDICATIONS & USAGE

Apply liberally with each diaper change or when the diaper is soiled.
KEEP OUT OF REACH OF CHILDREN

Keep this ointment away from children.
DOSAGE & ADMINISTRATION

10 g
PURPOSE

To provide relief from diaper rashes
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUTT BUTTER
zinc oxide ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
COD LIVER OIL (UNII: BBL281NWFG)	5 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71976-101-01	1 g in 1 JAR; Type 6: Drug/Biologic Combination	01/08/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/08/2018

Labeler - Littles Skin Care, Incorporated (058087047)

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