FDA.reportPublic FDA data

OLP Scar Cream

Manufacturer
Ohio Lab Pharma
Effective date
2017-10-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:03:03

Label at a glance#

ProductOLP Scar Cream
Active ingredientALLANTOIN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Allantoin 0.5%

Keep out of reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children: Keep out of reach of babies and children

DOSAGE & ADMINISTRATION SECTION

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

OTC - PURPOSE SECTION

Purpose: Skin Protectant

INDICATIONS & USAGE SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • 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

WARNING

WARNINGS SECTION

Warning: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately

Warnings

WARNINGS AND PRECAUTIONS SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and babies

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

scar creamscar cream

Maximum strength

Net weight 0.7 oz (20g)

NDC#70648-333-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70648-333-012020-08-25C16284748780-19d75b9d0-121f-f424-e053-dadaa90a57ce5b5cef63-d528-05e3-e053-2a91aa0a47f8
70648-333-012020-01-31C16284748780-19d75b9d0-121f-f424-e053-dadaa90a57ce5b5cef63-d528-05e3-e053-2a91aa0a47f8

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70648-33370648-333-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
EDETATE DISODIUM DIHYDRATE7FLD91C86KIACT
MINERAL OILT5L8T28FGPIACT
METHYLPARABENA2I8C7HI9TIACT
THYMUS VULGARIS LEAFGRX3499643IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PORTULACA OLERACEA WHOLED5J3623SV2IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
ALLANTOIN344S277G0ZACTIB
STEARIC ACID4ELV7Z65APIACT
ROSMARINUS OFFICINALIS WHOLEEA3289138MIACT
JASMINUM OFFICINALE FLOWER0Q8K841432IACT
MATRICARIA CHAMOMILLA LEAF6I9LN466F0IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7b9c7b3e-3ce6-9323-e053-2a91aa0a13da5b5cef63-d528-05e3-e053-2a91aa0a47f82020-08-11WarningsExact identifier
spl set id: 5b5cef63-d528-05e3-e053-2a91aa0a47f8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.