Smart Care Baby Diaper Rash And Skin Protectant
FDA Label NDC 70108-073
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ashtel Studios, Inc for the product Smart Care Baby Diaper Rash And Skin Protectant (NDC 70108-073). 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 drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Lanolin 15.5%
Petrolatum 53.4%
Purpose
Diaper rash ointment
Skin protectant
Uses
• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness
• temporarily protects minor:
• cuts • scrapes • burns
• temporarily protects and helps relieve chapped or cracked skin and lips
Warnings
For external use only
Do not use on
• deep or puncture wounds
• animal bites • serious burns
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 again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• for diaper rash use:
• 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 when exposure to wet diapers may be prolonged
• for skin protectant use: apply as needed
Other Information
store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
cod liver oil (contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin
Questions? +1-877-274-8358
You may report serious side effects to this phone number. Mon - Fri 8:00 AM - 5:00 PM PST
Packaging
Image (7010807301 4)
Image (7010807301 5)
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