KENDALL MOISTURE BARRIER- dimethicone cream

Kendall Moisture Barrier by

Drug Labeling and Warnings

Kendall Moisture Barrier by is a Otc medication manufactured, distributed, or labeled by Covidien Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Dimethicone 5%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Use

temporarily protects chapped or cracked skin.

WARNINGS

Warnings

For external use only.

When using this product 

• do not get into eyes
  

Do not use on 

• deep or puncture wounds
• animal bites
• serious burns
  

Stop use and ask a doctor if

• condition worsens
• symptoms last more than seven days or 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.

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

Directions

• apply as needed
  

SPL UNCLASSIFIED SECTION

Other Information

• protect from freezing
• avoid excessive heat
  

INACTIVE INGREDIENT

Inactive ingredients

Water, simmondsia chinensis (jojoba) seed oil, zea mays (corn) starch, cetearyl alcohol, glyceryl stearate, cirtus aurantium bergamia (bergamot) fruit oil, citrus medica vulgaris peel oil, sodium stearoyl lactylate, retinyl palmitate, tocopheryl acetate, isopropyl palmitate, propylene glycol, triethanolamine, sodium PCA, carbopol, butyrospermum parkii (shea butter), phenoxyethanol, methylparaben, butylparaben, propylparaben, isobutylparaben, ethylparaben

QUESTIONS

Questions or comments?  1-800-962-9888

PRINCIPAL DISPLAY PANEL

Image of Kendall Moisture Barrier Cream 2 Fl oz Label

INGREDIENTS AND APPEARANCE

KENDALL MOISTURE BARRIER 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28851-693
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	5.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
JOJOBA OIL (UNII: 724GKU717M)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BERGAMOT OIL (UNII: 39W1PKE3JI)
TROLAMINE (UNII: 9O3K93S3TK)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CARBOMER 1342 (UNII: 809Y72KV36)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
ETHYLPARABEN (UNII: 14255EXE39)
SHEA BUTTER (UNII: K49155WL9Y)
ACETATE ION (UNII: 569DQM74SC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 28851-693-01	59 mL in 1 TUBE
2	NDC: 28851-693-02	118 mL in 1 TUBE
3	NDC: 28851-693-03	4 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/21/2011

Labeler - Covidien Inc. (805770828)