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Mustela

Expanscience Laboratoires d/b/a Mustela

mustela DERMO-PEDIATRICS STELACTIV


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Zinc oxide 10 %

Purpose

skin protectant

Mustela 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

  • do not get into 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 the 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 any time when exposure to wet diapers may be prolonged.

Inactive ingredients

WATER, ZINC OXIDE, MINERAL OIL, METHYL GLUCOSE DIOLEATE, PROPYLENE GLYCOL DIETHYLHEXANOATE, PEG-45/DODECYL GLYCOL COPOLYMER, TITANIUM DIOXIDE, GLYCERIN, CERESIN, PANTHENOL, 1,2-HEXANEDIOL, ETHYL LINOLEATE, BUTYROSPERMUM PARKII (SHEA BUTTER), LUPINUS ALBUS SEED EXTRACT, MALTODEXTRIN, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, DISODIUM EDTA, MAGNESIUM SULFATE, GENISTEIN, SODIUM HYDROXIDE, CITRIC ACID.

Serious side effects?

Call 1-800-422-2987

www.mustela.com

PRINCIPAL DISPLAY PANEL - 83 g Tube Carton

mustela ®

DERMO-PEDIATRICS

FOR MODERATE
TO SEVERE DIAPER RASH

STELACTIV ®

Skin protectant cream
with enzyme-fighting agents

Contains 10% zinc oxide
Purifies - Soothes

Patented specific ingredient of natural origin
Fragrance-free - colorant-free
paraben-free formula

83 g/2.9 OZ

HYPOALLERGENIC

EXPANSCIENCE ®
LABORATOIRES

Mustela

Mustela

Zinc Oxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64768-2918
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Zinc Oxide Zinc oxide 8.3 g

Inactive Ingredients

Ingredient Name Strength
water
Mineral Oil
PEG-120 METHYL GLUCOSE DIOLEATE
PROPYLENE GLYCOL DIETHYLHEXANOATE
titanium dioxide
GLYCERIN
PANTHENOL
ETHYL LINOLEATE
SHEA BUTTER
maltodextrin
CAPRYLYL GLYCOL
GLYCERYL CAPRYLATE
EDETATE DISODIUM
MAGNESIUM SULFATE, UNSPECIFIED
GENISTEIN
SODIUM HYDROXIDE
CITRIC ACID MONOHYDRATE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 55 in 1 TUBE
2 NDC:64768-2918-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2010-07-19


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