Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 342b4fdf-85df-4af8-9ae0-0b79fa706e68
Route
TOPICAL
Published
Effective Date 2015-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (1 g)
Inactive Ingredients
Sorbitol Dimethicone Jojoba Oil Threonine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-02-01

Description

glycerin


Medication Information

Warnings and Precautions

do not use for ophthalmology because the safety for such use is not yet examined

keep in a room temperature

keep out of the direct sunlight



Indications and Usage

apply the cream to the diseased part

adjust the number of times being applying the cream, depending on symptom

it is better to increase the number of times for the quick recovery

for the oral disease, it is recommended to mop the cream after applying the medium dose several times a day



Dosage and Administration

topical use only



Description

glycerin

Section 50565-1

keep out of reach of the children



Section 51727-6

water, sorbitol, glyceryl stearate, isopropyl palmitate, stearic acid, dimethicone, mineral oil, malmiticacid, aloe barbadensis leaf ext, squalane oil, jojoba oil, rosemary oil, pca-na, betaine, serine, glutamic acid, alanine, lycine, arginine, threonine, proline, aminocaproic acid, methylparaben, propylparaben, phenoxyethanol, sodiumhydrogen-n(-1-oxooctadecyl)-L glutamate, sodium copper-chlorophyllin, sodium iodide



Section 51945-4
Section 55105-1

skin ailments

external lesion on the skin

lesion on the scalp

secondary infectin of the lesions described on the above

female external genitals

functionality change on the skin

cosmetic use as basic lotion

diseases of oral cavity



Section 55106-9

glycerin




Structured Label Content

Indications and Usage (34067-9)

apply the cream to the diseased part

adjust the number of times being applying the cream, depending on symptom

it is better to increase the number of times for the quick recovery

for the oral disease, it is recommended to mop the cream after applying the medium dose several times a day



Dosage and Administration (34068-7)

topical use only



Warnings and Precautions (34071-1)

do not use for ophthalmology because the safety for such use is not yet examined

keep in a room temperature

keep out of the direct sunlight



Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

water, sorbitol, glyceryl stearate, isopropyl palmitate, stearic acid, dimethicone, mineral oil, malmiticacid, aloe barbadensis leaf ext, squalane oil, jojoba oil, rosemary oil, pca-na, betaine, serine, glutamic acid, alanine, lycine, arginine, threonine, proline, aminocaproic acid, methylparaben, propylparaben, phenoxyethanol, sodiumhydrogen-n(-1-oxooctadecyl)-L glutamate, sodium copper-chlorophyllin, sodium iodide



Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

skin ailments

external lesion on the skin

lesion on the scalp

secondary infectin of the lesions described on the above

female external genitals

functionality change on the skin

cosmetic use as basic lotion

diseases of oral cavity



Section 55106-9 (55106-9)

glycerin




Advanced Ingredient Data


Raw Label Data

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