Active Ingredient
Zinc Oxide 40%
Diaper Rash
FDA Label NDC 63941-418
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Valu Merchandisers, Co. for the product Diaper Rash (NDC 63941-418). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash
- helps seal out wetness
Warnings
For external and/or intrarectal 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 within a few days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- change wet and soiled diapers promptly
- clean the diaper area
- allow to dry
- apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged
Other Information
store at 20 to 25C (68 to 77F)
Inactive Ingredients
butylated hydroxytoluene, cod liver oil, fd&c yellow #4, lanolin, methyl paraben, paraffin wax, purified water, talc powder, white petrolatum
Questions Or Comments?
Call toll free: 1-800-883-0085
Package Label
Diaper Rash Cream
Carton (Bcdiaperrash.carton)
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