Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8f31c5a5-4104-7487-e053-2a95a90a233e
Route
TOPICAL
Published
Effective Date 2019-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (3 g)
Inactive Ingredients
Niacinamide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-08-02

Description

glycerin


Medication Information

Warnings and Precautions

discontinue use if irritation or rash appears

avoid using on injured skin

keep out of childres

store out of direct sunlight

Indications and Usage

apply proper amount to the skin

Dosage and Administration

for topical use only

Description

glycerin

Section 50565-1

keep out of reach of the children

Section 51727-6

Tuber Melanosporum Extract

Aureobasidium Pullulans Ferment Extract

Butylene Glycol

Caprylic/Capric Triglyceride

Cyclopentasiloxane

Water

Glycerin

1,2-Hexanediol

Niacinamide

Cetearyl Alcohol

Cyclohexasiloxane

Dimethicone

Panthenol

Argania Spinosa Kernel Oil

Beeswax

C14-22 Alcohols

Sorbitan Olivate

Glyceryl Caprylate

Hydrogenated Polyisobutene

Dimethiconol

Glyceryl Stearate

PEG-100 Stearate

Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer

Arginine

Isohexadecane

Cetearyl Glucoside

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Perfume

Tocopheryl Acetate

Allantoin

C12-20 Alkyl Glucoside

Polysorbate 80

Adenosine

Sodium Hyaluronate

Disodium EDTA

Dipotassium Glycyrrhizate

Glycine

Serine

Glutamic Acid

Aspartic Acid

Leucine

Caprylyl Glycol

Alanine

Lysine

Ethylhexylglycerin

Tyrosine

Phenylalanine

Valine

Threonine

Proline

Isoleucine

Histidine

Methionine

Cysteine

Tocopherol

Anemarrhena Asphodeloides Root Extract

Acetyl Octapeptide-3

Acetyl Hexapeptide-22

Acetyl Hexapeptide-8

sh-Pentapeptide-19

sh-Octapeptide-4

Oligopeptide-28

sh-Decapeptide-7

Caffeoyl Tripeptide-1

Sh-Oligopeptide-1

Section 51945-4

Section 55105-1

anti-wrinkle

Section 55106-9

glycerin


Structured Label Content

Indications and Usage (34067-9)

apply proper amount to the skin

Dosage and Administration (34068-7)

for topical use only

Warnings and Precautions (34071-1)

discontinue use if irritation or rash appears

avoid using on injured skin

keep out of childres

store out of direct sunlight

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Tuber Melanosporum Extract

Aureobasidium Pullulans Ferment Extract

Butylene Glycol

Caprylic/Capric Triglyceride

Cyclopentasiloxane

Water

Glycerin

1,2-Hexanediol

Niacinamide

Cetearyl Alcohol

Cyclohexasiloxane

Dimethicone

Panthenol

Argania Spinosa Kernel Oil

Beeswax

C14-22 Alcohols

Sorbitan Olivate

Glyceryl Caprylate

Hydrogenated Polyisobutene

Dimethiconol

Glyceryl Stearate

PEG-100 Stearate

Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer

Arginine

Isohexadecane

Cetearyl Glucoside

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Perfume

Tocopheryl Acetate

Allantoin

C12-20 Alkyl Glucoside

Polysorbate 80

Adenosine

Sodium Hyaluronate

Disodium EDTA

Dipotassium Glycyrrhizate

Glycine

Serine

Glutamic Acid

Aspartic Acid

Leucine

Caprylyl Glycol

Alanine

Lysine

Ethylhexylglycerin

Tyrosine

Phenylalanine

Valine

Threonine

Proline

Isoleucine

Histidine

Methionine

Cysteine

Tocopherol

Anemarrhena Asphodeloides Root Extract

Acetyl Octapeptide-3

Acetyl Hexapeptide-22

Acetyl Hexapeptide-8

sh-Pentapeptide-19

sh-Octapeptide-4

Oligopeptide-28

sh-Decapeptide-7

Caffeoyl Tripeptide-1

Sh-Oligopeptide-1

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

anti-wrinkle

Section 55106-9 (55106-9)

glycerin


Advanced Ingredient Data


Raw Label Data

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