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Earth Baby Soothe N Comfort Diaper Rash Cream

Medically reviewed on January 13, 2018

Dosage form: cream
Ingredients: ZINC OXIDE 10g in 100g
Labeler: Earth Baby, Inc
NDC Code: 62588-804

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.

Active Ingredients Purpose

Zinc Oxide 10% Skin Protectant

Uses:

Helps protect against diaper rash and irritation.

For external use only

When using this product

Keep out of eyes

Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts or does not improve within 7 days. This may be the sign of a serious condition.

Directions:

Change Diaper promptly. Clean diaper area, allow to dry. Apply a generous amount of cream with each diaper change and before bedtime.

Inactive Ingredients: Avena SAtiva (Oat) Kernel Protein, Butylene Glycol, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes/Seed Oil, Corn Starch, Fragrance containing Chamomile Oil, Lavender Oil and Vanilla, 1,2-Hexanediol, Jojoba Oil, Petrolatum, Potassium Jojobate, Rosmarinus Officinalis (Rosemary) Flower/Leaf/Stem Extract, Water, Fragaria Vesca (Strawberry) Fruit Extract (Fresh Cells).

Like all drugs, keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately..

EARTH BABY SOOTHE N COMFORT  DIAPER RASH CREAM
zinc oxide 10% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62588-804
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
OAT KERNEL OIL 
BUTYLENE GLYCOL 
CAPRYLYL GLYCOL 
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES 
STARCH, CORN 
CHAMOMILE FLOWER OIL 
LAVENDER OIL 
VANILLA 
1,2-HEXANEDIOL 
PETROLATUM 
ROSMARINUS OFFICINALIS WHOLE 
WATER 
STRAWBERRY 
Packaging
#Item CodePackage Description
1NDC:62588-804-0257 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/201601/31/2019
Labeler - Earth Baby, Inc (079298651)

 
Earth Baby, Inc

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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