Honest Calm & Heal Melting Balm

Honest Calm & Heal Melting Balm
SPL v4
SPL
SPL Set ID b08a1bd6-986d-9520-e053-2995a90a865e
Route
TOPICAL
Published
Effective Date 2021-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.5 g)
Inactive Ingredients
Polyhydroxystearic Acid (2300 Mw) Polyglycerin-6 Medium-chain Triglycerides Lecithin, Soybean Trisodium Ethylenediamine Disuccinate Water Sunflower Oil Rice Bran Soy Sterol Butyrospermum Parkii (shea) Butter Unsaponifiables Sodium Acetylated Hyaluronate Maltodextrin Isostearyl Hydroxystearate Tocopherol Ophiopogon Japonicus Root Ascorbyl Palmitate Magnesium Sulfate, Unspecified Hydroxyacetophenone Propanediol Glycerin 1,2-hexanediol Caprylyl Glycol Isostearyl Alcohol Polyglyceryl-2 Dipolyhydroxystearate Linoleic Acid Polyglyceryl-6 Polyricinoleate Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-29

Description

Active ingredient Allantoin 0.5%


Medication Information

Warnings and Precautions

Warnings For external use only

Indications and Usage

Uses

  • Temporarily protects minor:

•cuts

•scrapes

•burns

  • Helps prevent and helps relieve chapped or cracked skin
  • Helps prevent and protect from the drying effects of wind and cold weather
Dosage and 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.

Description

Active ingredient Allantoin 0.5%

Section 42229-5

Other information: Store at room temperature

Section 50565-1

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9

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
Section 50567-7

When using this product do not get into eyes.

Section 51727-6

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

Section 51945-4

Section 55105-1

Purpose skin protectant

Section 55106-9

Active ingredient Allantoin 0.5%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • Temporarily protects minor:

•cuts

•scrapes

•burns

  • Helps prevent and helps relieve chapped or cracked skin
  • Helps prevent and protect from the drying effects of wind and cold weather
Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings For external use only

Section 42229-5 (42229-5)

Other information: Store at room temperature

Section 50565-1 (50565-1)

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product do not get into eyes.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose skin protectant

Section 55106-9 (55106-9)

Active ingredient Allantoin 0.5%


Advanced Ingredient Data


Raw Label Data

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