Drug Labeling and Warnings

Drug Details

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TENA PROTECTIVE CREAM- zinc oxide cream 
SCA Personal Care 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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Drug Facts

Active ingredient

Zinc Oxide 10%

Purpose

Skin Protectant

Uses

  • helps treat and prevent minor skin irritation assoicated with incontinence
  • protects and helps relieve chafed, chapped or cracked skin

Warnings

For external use only

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or 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

  • gently cleanse skin as required
  • apply cream sparingly to affected area and reapply as needed

Other information

  • store at a temperature between 32°Fand 85°F

Inactive ingredients

benzoic acid, betaine, canola oil, caprylic/capric triglyceride, cera alba, dehydroacetic acid, ethylhexyl stearate, glycerin, glyceryl oleate, hydrogenated vegetable oil, magnesium stearate, magnesium sulfate, panthenol, phenoxyethanol, polyglyceryl-3 ricinoleate, tocopheryl acetate, water

 Questions or comments?

Call 1-800-992-9939 or visit www.tena-usa.com

Principal Display Panel

TENA Protective Cream

Irritated & sensitive skin

Scent Free

10% zinc oxide

Principal Display Panel -Tube

TENA PROTECTIVE CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59608-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CANOLA OIL (UNII: 331KBJ17RK)  
TRICAPRIN (UNII: O1PB8EU98M)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
WHITE WAX (UNII: 7G1J5DA97F)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
BETAINE (UNII: 3SCV180C9W)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
PANTHENOL (UNII: WV9CM0O67Z)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MAGNESIUM PALMITATE (UNII: JJ0UR696JR)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59608-001-0210 in 1 BOX10/03/2013
1100 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 59608-001-01100 mL in 1 TUBE; Type 0: Not a Combination Product10/03/2013
3NDC: 59608-001-04500 in 1 CASE10/03/2013
35 mL in 1 PACKET; Type 0: Not a Combination Product
4NDC: 59608-001-035 mL in 1 PACKET; Type 0: Not a Combination Product10/03/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/03/2013
Labeler - SCA Personal Care Inc. (790100549)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(59608-001) , label(59608-001) , pack(59608-001)

Revised: 11/2016
 
SCA Personal Care Inc.


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