Drug Facts

Active Ingredient

Zinc Oxide 14%

Purpose

Skin protectant

Uses

Temporarily protects minor:
cuts
scrapes
burns
Temporarily protects chapped or cracked skin.
Dries the oozing and weeping of poison:
ivy
oak
sumac

Warnings

For external use only

Do not use on

deep or puncture wound
animal bites
serious burns

When using this product

do not get into eyes.

Stop use and ask a doctor if

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use

Directions

apply as needed

Inactive ingredients:

Beeswax, Cholecalciferol (Vitamin D3), Glycerin, Lanolin, Oat Protein, Petrolatum, Retinyl Palmitate (Vitamin A), Zea Mays (Corn) Starch

Other information:

Protect the product in this container from excessive heat and direct sun.

Questions?

1-732-852-2596

Package Labeling:

Label

EARLY MOMMY BABY BUM BUTTA
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81638-171
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	140 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
PETROLATUM (UNII: 4T6H12BN9U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
STARCH, CORN (UNII: O8232NY3SJ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81638-171-00	118 mL in 1 JAR; Type 0: Not a Combination Product	03/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	03/01/2021

Labeler - TEKT TONE LABS LLC (044494980)

EARLY MOMMY Baby Bum Butta