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Diaper Rash by CoValence, Inc.

Medically reviewed on October 2, 2017

Dosage form: ointment
Ingredients: Zinc Oxide .1g in 1g
Labeler: CoValence, Inc.
NDC Code: 66915-300

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.

Baby Mantra Diaper Rash Ointment

Active Ingredient:

Zinc Oxide

Purpose:

Skin Protectant

Uses:
  • Helps treat and prevent diaper rash.
  • Protects chafed skin due to diaper rash and helps protect skin from wetness.
  • Helps prevent and temporarily protect chafed, chapped, cracked or wind-burned skin and lips.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings:

When using this product do not get into eyes.

Stop use and ask a doctor if

  • condidion worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns.

Other Information:

Store at room temperature.

Directions:
  • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
  • Apply ointment liberally, as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diaper may be prolonged.

Inactive Ingredients:

Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax (White), Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol (D-alpha), Aqua (Water), Alcohol

DIAPER RASH 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66915-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER1 g  in 1 g
Packaging
#Item CodePackage Description
1NDC:66915-300-01200000 g in 1 DRUM
2NDC:66915-300-02100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/02/2014
Labeler - CoValence, Inc. (070653204)
Registrant - CoValence, Inc. (070653204)
Establishment
NameAddressID/FEIOperations
CoValence, Inc.070653204manufacture(66915-300)

 
CoValence, Inc.

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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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