Otc - Active Ingredient
Active ingredient Allantoin 0.5%
Calm And Heal Melting Balm Cream
FDA Label NDC 69366-505
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 Honest Company, Inc. for the product Calm And Heal Melting Balm (NDC 69366-505). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose skin protectant
Indications & Usage
Uses
- Temporarily protects minor:
- Helps prevent and helps relieve chapped or cracked skin
- Helps prevent and protect from the drying effects of wind and cold weather
•cuts
•scrapes
•burns
Warnings
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 immediately
Dosage & Administration
Directions Apply as needed. Warm up product in hands to transform the rich cream to a silky balm, then gently massage a thin layer onto skin.
Other
Other information: Store at room temperature
HONEST BEAUTY ®
CALM & HEAL MELTING BALM
designed for dry skin
with calming phyto-blemd™ + allantoin
+ mondo grass root extract
©2021 Dist. by
The Honest Company, Inc.
Los Angeles, CA 90094
Net Wt. 1.7 oz. / 50 g
Inactive Ingredient
Inactive ingredients Water (Aqua/Eau),Helianthus Annuus (Sunflower) Seed Oil,Caprylic/Capric Triglyceride,Oryza Sativa (Rice) Bran Wax,Polyhydroxystearic Acid, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Magnesium Sulfate,Propanediol,Glycerin, Butyrospermum Parkii (Shea) Butter, Phytosterols,Phospholipids, Linoleic Acid, Hydrolyzed Sodium Hyaluronate, Sodium Acetylated Hyaluronate, Ophiopogon Japonicus Root Extract, Maltodextrin, Polyglycerin-6, Trisodium Ethylenediamine Disuccinate, Isostearyl Hydroxystearate, Hydroxyacetophenone, 1,2-Hexanediol, Caprylyl Glycol,Isostearyl Alcohol,Tocopherol, Ascorbyl Palmitate
Package Label.Principal Display Panel
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