MUSTELA DIAPER RASH 1 2 3- zinc oxide cream

MUSTELA Diaper Rash 1 2 3 by

Drug Labeling and Warnings

MUSTELA Diaper Rash 1 2 3 by is a Otc medication manufactured, distributed, or labeled by Expanscience Laboratories d/b/a Mustela, Laboratoires Expanscience d/b/a Mustela. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide 9.9 %

Purpose

skin protectant

Uses

• Helps treat and prevent diaper rash
• Protects chafed skin and minor irritation associated with diaper rash
• Helps seal out wetness

Warnings

For external use only.

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• conditions worsen
• symptoms last more than seven days
• symptoms 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.

Directions

Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally and as often as necessary and with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other information

You may report serious side effects to the phone number provided below or to Expanscience Laboratories Inc. dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022, USA.

Alumino-plastic tube ensures proper product conservation and facilitates daily use.

Inactive ingredients

BEESWAX, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLOYL GLYCINE, CAPRYLYL GLYCOL, COCO-CAPRYLATE/CAPRATE, ETHYL LINOLEATE, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, LEVULINIC ACID, MAGNESIUM SULFATE, PERSEA GRATISSIMA (AVOCADO) FRUIT EXTRACT, PERSEA GRATISSIMA (AVOCADO) OIL, POLYGLYCERYL-2-DIPOLYHYDROXYSTEARATE, POLYGLYCERYL-3 DIISOSTEARATE, PROPYLENE CARBONATE, SODIUM LEVULINATE, STEARALKONIUM HECTORITE, UNDECYL DIMETHYL OXAZOLINE, WATER

Questions or comments ?

Call toll free 1-800-422-2987 Monday-Friday 9:00am-5:00pm EST

Company information

Distributed in USA by

Expanscience Laboratories

dba Mustela, New York, NY 10022, USA

PRODUCT PACKAGING - 108 g Tube Carton

Mustela ®

FRAGRANCE FREE

DIAPER RASH CREAM

Skin Protectant
with Zinc Oxide

1
PREVENTS

2
RELIEVES

3
RECOVERS

IRRITATION and REDNESS

98% INGREDIENTS OF NATURAL ORIGIN

0% FRAGRANCE

FROM BIRTH ON
CLINICALLY TESTED
HYPOALLERGENIC

Net Wt. 108g/3.80 OZ

EXPANSCIENCE ®
LABORATOIRES

INGREDIENTS AND APPEARANCE

MUSTELA DIAPER RASH 1 2 3 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64768-2922
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LEVULINIC ACID (UNII: RYX5QG61EI)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
AVOCADO (UNII: SDS87L369F)
AVOCADO OIL (UNII: 6VNO72PFC1)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
4,4-DIMETHYLOXAZOLIDINE (UNII: 96J42P99ZA)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64768-2922-1	1 in 1 CARTON	01/09/2017
1		107.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/09/2017

Labeler - Expanscience Laboratories d/b/a Mustela (181191057)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Expanscience d/b/a Mustela		347941502	manufacture(64768-2922)