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Tender Moments Baby Bottom Balm

Dosage form: cream
Ingredients: ZINC OXIDE 10mL in 100mL, DIMETHICONE 2mL in 100mL
Labeler: JAFRA COSMETICS INTERNATIONAL
NDC Code: 68828-095

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.

Tender moments Baby Bottom Balm

Active Ingredients: Zinc Oxide/CI77947, Dimethicone

Soothing balm for baby's tender bottom that helps treat and prevent diaper rash.

No Such information

If condition worsens or does not improve within 7 days, consult a doctor.

For external use only. Avoid contact with eyes

To use: With each diaper change, cleanse the diaper area and and allow to dry. Apply baby bottom balm liberally, especially when exposure to wet diapers may be prolonged.

Other ingredients: Water/aqua, petrolatum, Diisostearoyl Polyglyceryl-3 Diisostearate, Ethylhexyl stearate, Avena Sativa (Oat) Kernel Extract, Aloe Barbadensis Oil, Butyrospermum Parkii (Shea Butter) Fruit, Panthenol, Glycine Soja (Soybean) Oil. Cetyl Dimethicone, Magnesium Sulfate, Beeswax/Cera Alba, Butylene Glycol, DMDM Hydantoin, PEG-4 Laurate, Iodopropynyl Butylcarbamate.



Tender Moments

Baby Bottom Balm

Crema Suavizante para Rozaduras


Jafra 

 50 ml 1.7 fl. oz



TENDER MOMENTS  BABY BOTTOM BALM
zinc oxide, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-095
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE10 mL  in 100 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PETROLATUM 
ISOPROPYL PALMITATE 
OAT 
PANTHENOL 
SOYBEAN OIL 
CETOSTEARYL ALCOHOL 
MAGNESIUM SULFATE 
WHITE WAX 
BUTYLENE GLYCOL 
DMDM HYDANTOIN 
PEG-4 LAURATE 
IODOPROPYNYL BUTYLCARBAMATE 
Packaging
#Item CodePackage Description
1NDC:68828-095-011 TUBE (TUBE) in 1 BOX
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34706/07/2012
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIOperations
Jafra Manufacturing, S.A. de C.V.814732061manufacture

Revised: 06/2012
 
JAFRA COSMETICS INTERNATIONAL

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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