KENDALL SOOTHING - zinc oxide ointment 
Covidien Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Kendall Soothing Ointment

Active Ingredient

Zinc oxide 10%

Purpose

Skin protectant

Use

temporarily protects chapped or cracked skin.

Warnings

For external use only.

When using this product 
Do not use on 
Stop use and ask a doctor if
Keep out of the reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.



Directions

Other Information

Inactive ingredients

Water, Polysorbate 60, petrolatum, sorbitan stearate, cetyl alcohol, propylene glycol, dimethicone, simmondsia chinensis (jojoba) seed oil, decylene glycol, xanthan gum, cetyl hydroxyethylcellulose, citrus aurantium bergamia (bergamot) fruit oil, citrus medica vulgaris peel oil, retinyl palmitate, tocopheryl acetate, methylparaben, propylparaben, diazolidinyl urea

Questions or comments?  1-800-962-9888


Image of Kendall Soothing Ointment 2 Fl oz Label

Image of Kendall Soothing Ointment 2 Fl oz Label





KENDALL SOOTHING 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28851-695
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc - UNII:J41CSQ7QDS) Zinc Oxide10 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ACETATE ION (UNII: 569DQM74SC)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
JOJOBA OIL (UNII: 724GKU717M)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
1-DECENE (UNII: 7O4U4C718P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:28851-695-0159 mL in 1 TUBE
2NDC:28851-695-02118 mL in 1 TUBE
3NDC:28851-695-034 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/22/2011
Labeler - Covidien Inc. (805770828)

Revised: 4/2011
Document Id: 472d414c-1970-415f-b1ab-85bd657d6e74
Set id: 46bffc62-3cd5-4493-880c-037feb7b346c
Version: 2
Effective Time: 20110427
 
Covidien Inc.