SPL v2
SPL
SPL Set ID c76c4bc7-1f7b-252e-e053-2a95a90aa215
Route
TOPICAL
Published
Effective Date 2021-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Adenosine (0.04 g) Niacinamide (2 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-07-19

Description

niacinamide, allantoin


Medication Information

Warnings and Precautions

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

Indications and Usage

apply where needed

Dosage and Administration

for external use only

Description

niacinamide, allantoin

Section 50565-1

Keep Out of Reach of Children.

Section 51727-6

Water

Hamamelis Virginiana (Witch Hazel) Water

Butylene Glycol

Niacinamide

Dipropylene Glycol

1,2-Hexanediol

Glycerin

Camellia Sinensis Leaf Extract

Bambusa Vulgaris Extract

Rosmarinus Officinalis (Rosemary) Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Centella Asiatica Extract

Portulaca Oleracea Extract

Nelumbo Nucifera Flower Extract

Olea Europaea (Olive) Fruit Extract

Melaleuca Alternifolia (Tea Tree) Extract

Tremella Fuciformis (Mushroom) Extract

Salvia Officinalis (Sage) Leaf Extract

Salix Alba (Willow) Bark Extract

PEG-60 Hydrogenated Castor Oil

Ammonium Acryloyldimethyltaurate/VP Copolymer

Lactose

Arginine

Carbomer

Panthenol

Allantoin

Cellulose

Adenosine

Hydroxypropyl Methylcellulose

Glyceryl Acrylate/Acrylic Acid Copolymer

Mica

Ethylcellulose

Titanium Dioxide

PEG-150

Hydrogenated Lecithin

Jojoba Esters

Polyglyceryl-10 Stearate

Disodium EDTA

Tocopheryl Acetate

Ascorbyl Palmitate

Sodium Ascorbyl Phosphate

Sodium Hyaluronate

Glyceryl Linolenate

Glyceryl Arachidonate

Retinyl Palmitate

Biotin

Thiamine HCl

Folic Acid

Pyridoxine

Cyanocobalamin

Ethylhexylglycerin

Caprylyl Glycol

Fragrance

CI 77492

CI 19140

CI 15985

Section 51945-4

Section 55105-1

Skin whitening, wrinkle care

Section 55106-9

niacinamide, allantoin


Structured Label Content

Indications and Usage (34067-9)

apply where needed

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

Section 50565-1 (50565-1)

Keep Out of Reach of Children.

Section 51727-6 (51727-6)

Water

Hamamelis Virginiana (Witch Hazel) Water

Butylene Glycol

Niacinamide

Dipropylene Glycol

1,2-Hexanediol

Glycerin

Camellia Sinensis Leaf Extract

Bambusa Vulgaris Extract

Rosmarinus Officinalis (Rosemary) Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Centella Asiatica Extract

Portulaca Oleracea Extract

Nelumbo Nucifera Flower Extract

Olea Europaea (Olive) Fruit Extract

Melaleuca Alternifolia (Tea Tree) Extract

Tremella Fuciformis (Mushroom) Extract

Salvia Officinalis (Sage) Leaf Extract

Salix Alba (Willow) Bark Extract

PEG-60 Hydrogenated Castor Oil

Ammonium Acryloyldimethyltaurate/VP Copolymer

Lactose

Arginine

Carbomer

Panthenol

Allantoin

Cellulose

Adenosine

Hydroxypropyl Methylcellulose

Glyceryl Acrylate/Acrylic Acid Copolymer

Mica

Ethylcellulose

Titanium Dioxide

PEG-150

Hydrogenated Lecithin

Jojoba Esters

Polyglyceryl-10 Stearate

Disodium EDTA

Tocopheryl Acetate

Ascorbyl Palmitate

Sodium Ascorbyl Phosphate

Sodium Hyaluronate

Glyceryl Linolenate

Glyceryl Arachidonate

Retinyl Palmitate

Biotin

Thiamine HCl

Folic Acid

Pyridoxine

Cyanocobalamin

Ethylhexylglycerin

Caprylyl Glycol

Fragrance

CI 77492

CI 19140

CI 15985

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin whitening, wrinkle care

Section 55106-9 (55106-9)

niacinamide, allantoin


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