TOMS BABY DIAPER FRAGRANCE FREE- zinc oxide cream

Toms Baby Diaper Fragrance Free by

Drug Labeling and Warnings

Toms Baby Diaper Fragrance Free by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Accupac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc oxide 12%

Purpose

Skin protectant

Uses

• helps treat and prevent diaper rash.
• protects minor skin irritation associated with diaper rash and helps seal out wetness.

Warnings

For external use only

When using this product do not get into eyes.

Stop use and ask doctor if condition worsens

• symptoms last more than 7 days or clear up and occur within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

caprylic/capric triglyceride, Helianthus annuus (sunflower) seed oil, beeswax, hydrogenated castor oil, tocopheryl acetate (vitamin E acetate).

Other information

Store at 20°C to 25°C (68° F to 77° F).

Questions?

1-800-FOR TOMS (1-800-367-8667)

SPL UNCLASSIFIED SECTION

Dist. by Tom's of Maine, Inc., Kennebunk, ME 04043

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

New!

SINCE 1970
Tom's®
OF MAINE

baby

diaper cream

seals out wetness to help
treat & prevent diaper rash

pediatrician tested

fragrance free

natural

✓ NO Phthalates
✓ NO Parabens
✓ NO Phenoxyethanol

NET WT 3 OZ (85g)

INGREDIENTS AND APPEARANCE

TOMS BABY DIAPER FRAGRANCE FREE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.12 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Caprylic/Capric Acid (UNII: DI775RT244)
Sunflower Oil (UNII: 3W1JG795YI)
Yellow Wax (UNII: 2ZA36H0S2V)
Hydrogenated castor oil (UNII: ZF94AP8MEY)
.Alpha.-Tocopherol Acetate, dl- (UNII: WR1WPI7EW8)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-701-85	85 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2015	06/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	01/01/2015	06/01/2021

Labeler - Tom's of Maine (052764354)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		061595175	MANUFACTURE(51009-701)