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Natural Diaper Rash

Dosage form: cream
Ingredients: ZINC OXIDE 120mg in 1mL
Labeler: Products On The Go, LLC
NDC Code: 70668-827

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.

Natural Diaper Rash

Active Ingredients:

Zinc Oxide 12%

Skin Protection

Uses:
  • Helps treat and prevent diaper rash.
  • Protects chafed skin and minor irritation associated with diaper rash.
  • Helps seal out wetness.

WARNINGS:

For external use only.

When using this product,

avoid contact with eyes.

Stop use and ask a doctor if:
  • Conditions worsen.
  • Symptoms last more then seven days.

Keep out of reach of children.

if swallowed, get medical help immediately or contact poison control center right away.

DIRECTION:
  • Change wet and soiled diapers promptly.
  • Cleans the diaper area and allow to dry.
  • Apply cream liberally, as often as necessary, with each diaper change, especially at bed time or before any prolonged exposure to wet diapers.

Other infomation:

Store at 15° -30° C [59°-86°)

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera) Extract, Beeswax, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Chamomilla Recutita (Chamomile) Oil, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavendar) Oil, Tocopheryl Acetate (Vitamin E).

Package Labeling:

NATURAL DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70668-827
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC CATION120 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
YELLOW WAX 
SHEA BUTTER 
CALENDULA OFFICINALIS FLOWER 
CHAMOMILE 
COCONUT OIL 
CUCUMBER 
GLYCYRRHIZA GLABRA 
HELIANTHUS ANNUUS FLOWERING TOP 
LAVENDER OIL 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:70668-827-015 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/10/2017
Labeler - Products On The Go, LLC (060619487)

Revised: 05/2017
 
Products On The Go, LLC

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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