SPL v1
SPL
SPL Set ID 45fa7962-b489-4613-e063-6394a90a59b0
Route
TOPICAL
Published
Effective Date 2025-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (0.5 g)
Inactive Ingredients
Taraxacum Officinale (dandelion) Root Hyaluronic Acid Gentiana Scabra Root Human Skin Proteins, Partially Hydrolyzed Chondrus Crispus Carrageenan Potassium Hypophosphite Aqua Matricaria Chamomilla Whole Lonicera Japonica Flower Viola Philippica Whole Sodium Acetylated Hyaluronate Pvp Piper Methysticum Root Paeonia Lactiflora Root Malva Sylvestris Flowering Top Mentha Piperita (peppermint) Leaf Sodium Hyaluronate Taurine Aloe Barbadensis Leaf Powder

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-15

Description

Active ingredients CarboxymethylcelluloseSodium(CMC) 0.5% Purpose Emollient


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

temporarily relieves burningand irritation of the eye.prevent further irritation ofthe eye.

Dosage and Administration

Directions

Take an appropriate amountand apply it to the skin aroundthe eyelid.

Description

Active ingredients CarboxymethylcelluloseSodium(CMC) 0.5% Purpose Emollient

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive ingredients

Aqua(Water),Gentiana ScabraRoot Extract,Mentha Piperita(Peppermint)LeafWater,PipeMethysticum Leaf/Root/StemExtract,Sodium Hyaluronate,Taurine,ChamomillaRecutita(Matricaria) FlowerExtract,Viola Yedoensis Extract,Paeonia Albiflora Root Extract,Lonicera Japonica (Honeysuckle)Flower Extract,Taraxacum Officinale(Dandelion)Rhizome/Root Extract,Malva Sylvestris(Mallow)Flower Extract,AloeBarbadensis Leaf Juice,

Chondrus Crispus Extract,

Sodium Acetylated

Hyaluronate,HydrolyzedHyaluronic Acid,HyaluronicAcid,Sodium HyaluronateCrosspolymer,HydrolyzedSodium Hyaluronate,Potassium Hyaluronate.PVP

Section 51945-4

Section 55105-1

Helps with styes

Soothes lrritation

Gentle Formula

Section 55106-9

Active ingredients CarboxymethylcelluloseSodium(CMC) 0.5% Purpose Emollient


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves burningand irritation of the eye.prevent further irritation ofthe eye.

Dosage and Administration (34068-7)

Directions

Take an appropriate amountand apply it to the skin aroundthe eyelid.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive ingredients

Aqua(Water),Gentiana ScabraRoot Extract,Mentha Piperita(Peppermint)LeafWater,PipeMethysticum Leaf/Root/StemExtract,Sodium Hyaluronate,Taurine,ChamomillaRecutita(Matricaria) FlowerExtract,Viola Yedoensis Extract,Paeonia Albiflora Root Extract,Lonicera Japonica (Honeysuckle)Flower Extract,Taraxacum Officinale(Dandelion)Rhizome/Root Extract,Malva Sylvestris(Mallow)Flower Extract,AloeBarbadensis Leaf Juice,

Chondrus Crispus Extract,

Sodium Acetylated

Hyaluronate,HydrolyzedHyaluronic Acid,HyaluronicAcid,Sodium HyaluronateCrosspolymer,HydrolyzedSodium Hyaluronate,Potassium Hyaluronate.PVP

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps with styes

Soothes lrritation

Gentle Formula

Section 55106-9 (55106-9)

Active ingredients CarboxymethylcelluloseSodium(CMC) 0.5% Purpose Emollient


Advanced Ingredient Data


Raw Label Data

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