SPL v7
SPL
SPL Set ID d0381034-8cf7-5e8d-e053-2995a90a9faa
Route
TOPICAL
Published
Effective Date 2018-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.5 g)
Inactive Ingredients
Water Trolamine .alpha.-tocopherol Edetate Disodium Cetostearyl Alcohol Propylene Glycol Stearic Acid Mineral Oil Methylparaben Thymus Vulgaris Leaf 1,2-hexanediol Jasminum Officinale Flower Matricaria Chamomilla Leaf Rosmarinus Officinalis Whole Portulaca Oleracea Whole Polyoxyl 20 Cetostearyl Ether Propylparaben

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-01

Description

Allantoin 0.5%


Medication Information

Indications and Usage

Indication and Usage: Temporarily protects and helps relieve chapped or cracked skin.

Dosage and Administration

Dosage and Administration: Gently massage into scar twice a day for 2-3 minutes

Description

Allantoin 0.5%

Section 50565-1

Keep out of reach of children and babies

Section 55105-1

Purpose: Skin Protectant

Section 55106-9

Allantoin 0.5%

Warnings
  • In case of having the following symptoms after using this cream, you are advised to stop using it immediately. If you keep using it , the symptoms will get worse and need to consult a drematologist .1- in case of having problems such as red rash, swollllenness, itching, stimulation during usage. 2- in case of having the same symptoms above on the part you put this product on by direct sunlight
  • you are banned to use it on the part where you have a eczema, lor dermatitis.
  • in case of getting it into your eyes, you have to wash it immediately.
Questions

drspharmacy.com

Package Label

Inactive Ingredients

Cetostearyl alcohol- mineral oil- ceteareth 20- propylene glycol- methyl paraben- propylparaben- vitamin E- Stearic acid - trolamine RosmarinusOfficinalis (Rosemary)Extract/ Portulaca Oleracea Extract/Thymus Vulgaris Thyme) Leaf Extract/Jasminum Officinale (jasmine) Flower/ Leaf Extract?Chamomila) Recutita (Matricaria) Flower Water, Aureobasidium Pullulans Ferment Extract/ 1.2-Hexanedio


Structured Label Content

Indications and Usage (34067-9)

Indication and Usage: Temporarily protects and helps relieve chapped or cracked skin.

Dosage and Administration (34068-7)

Dosage and Administration: Gently massage into scar twice a day for 2-3 minutes

Section 50565-1 (50565-1)

Keep out of reach of children and babies

Section 55105-1 (55105-1)

Purpose: Skin Protectant

Section 55106-9 (55106-9)

Allantoin 0.5%

Warnings
  • In case of having the following symptoms after using this cream, you are advised to stop using it immediately. If you keep using it , the symptoms will get worse and need to consult a drematologist .1- in case of having problems such as red rash, swollllenness, itching, stimulation during usage. 2- in case of having the same symptoms above on the part you put this product on by direct sunlight
  • you are banned to use it on the part where you have a eczema, lor dermatitis.
  • in case of getting it into your eyes, you have to wash it immediately.
Questions

drspharmacy.com

Package Label (package label)

Inactive Ingredients

Cetostearyl alcohol- mineral oil- ceteareth 20- propylene glycol- methyl paraben- propylparaben- vitamin E- Stearic acid - trolamine RosmarinusOfficinalis (Rosemary)Extract/ Portulaca Oleracea Extract/Thymus Vulgaris Thyme) Leaf Extract/Jasminum Officinale (jasmine) Flower/ Leaf Extract?Chamomila) Recutita (Matricaria) Flower Water, Aureobasidium Pullulans Ferment Extract/ 1.2-Hexanedio


Advanced Ingredient Data


Raw Label Data

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