OLP SCAR CREAM- allantoin cream
Ohio Lab Pharma

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients: Allantoin 0.5%

Keep out of reach of Children

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

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

Purpose: Skin Protectant

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

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

WARNING

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

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

visit www.ohiolabpharma.us

Keep out of reach of children and babies

package label

scar cream

Maximum strength

Net weight 0.7 oz (20g)

NDC#70648-333-01

OLP SCAR CREAM
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70648-333
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70648-333-01	1 in 1 CARTON	10/12/2017
1		20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/12/2017	12/07/2017

Labeler - Ohio Lab Pharma (080215854)

Name	Address	ID/FEI	Business Operations
Establishment
Ohio Lab Pharma		080215854	manufacture(70648-333)

Revised: 8/2020

Document Id: 7b9c7b3e-3ce6-9323-e053-2a91aa0a13da

Set id: 5b5cef63-d528-05e3-e053-2a91aa0a47f8

Version: 2

Effective Time: 20200811

Ohio Lab Pharma