Active Ingredient(S)
1.0% Colloidal Oatmeal
0.5% Allantoin
Kenkoderm Eczema Honey Intensive Soothing Balm Cream
FDA Label NDC 84148-018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Ariel Biotech Co., Ltd. for the product Kenkoderm Eczema Honey Intensive Soothing Balm (NDC 84148-018). 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(s), purpose, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Warnings
Do not use on deep or puncture wounds, animal bites, serious burns.
Stop use and ask a doctor if condition worsens or
symptoms persist > 7 days. Keep out of reach of
children. If swallowed, get medical help or contact
a Poison Control Center immediately.
Do Not Use
Do not use on deep or puncture wounds,
Otc - When Using
If swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Stop Use
Stop use and ask a doctor if condition worsens or symptoms persist > 7 days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Information
Store at room temperature. Contains honey-not for infants < 12 months.
Inactive Ingredients
Mineral Oil, Beeswax, Butyrospermum parkii (Shea) Butter, Olea europaea (Olive) Fruit Oil, Vitis vinifera (Grape)
Seed Oil, Aloe barbadensis Leaf Water, Water (Aqua), Mel (Honey), Prunus amygdalus dulcis
(Sweet Almond) Oil, Helianthus annuus (Sunflower) Seed Oil, Avena sativa (Oat) Kernel
Oil, Magnesium Sulfate.
Directions
Adults and children 2 yrs and older: apply to
affected area as needed. Children under 2 yrs: ask
a doctor.
Uses
Temporarily protects and helps relieve minor
skin irritation and itching due to eczema, psoriasis,
rashes, or dry skin.
Package Label - Principal Display Panel
Undefined (Label)
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