Active Ingredients
White petrolatum 50.7%
Zinc oxide 40%
Buddle Diaper Rash Rescue Healing
FDA Label NDC 83178-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Goodsprout Company Llc for the product Buddle Diaper Rash Rescue Healing (NDC 83178-101). 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 ingredients, purposes, uses, warnings, otc - when using, otc - stop use, otc - 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
Purposes
White petrolatum 50.7% ...... Skin Protectant
Zinc oxide 40% .................... Skin Protectant
Uses
- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash and helps seal out wetness
Warnings
For external use only
Otc - When Using
When using this product
- do not get into eyes
Otc - Stop Use
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
- 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.
Other Information
- store at 20°C to 25°C (68°F to 77°F)
- may stain clothing
Inactive Ingredients
anhydrous lanolin, polyglyceryl-2 dipolyhydroxystearate, zea mays (corn) starch, beeswax white, ceramide AP, ceramide NP, ceramide EOP, honey, water, alpha-glucan oligosaccharide, lactobacillus ferment, taraxacum officinale (dandelion) leaf extract, inulin, phytosphingosine, cetyI alcohol, butylene glycol, carbomer, xanthan gum, ethylhexylglycerin, 1,2-hexanediol, sodium lauroyl lactylate, cholesterol
Questions?
Call 833-777-6880
Package Label.Principal Display Panel
RASH RESCUE
buddle
Diaper Rash
Healing Paste
Repair and replenish baby’s skin barrier and provide maximum protection
SKIN PROTECTANT
TREAT
NET WT 4 OZ (113g)
* Please review the disclaimer below.
