SPL v1
SPL
SPL Set ID 8041bbe5-8aa1-0905-e053-2991aa0a4805
Route
TOPICAL
Published
Effective Date 2019-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (4 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-01-24

Description

Apply enough amount on face by rubbing it outward along the skin texture, gently tap allowing it to absorb


Medication Information

Warnings and Precautions

Discontinue use of the product if any of the following symptoms occurred. Consult a dermatologist if the symptoms got worse.

a) If redness, Swelling, Itchiness, Irritation occurred during using.

b) If the above symptoms started to occur when exposed to direct sunlight.

Do not use on skins with wounds, eczema or dermatitis.

Storage instructions

a) Always close the lid after finish using.

b) Store in a safe place away and out of reach of children.

c) Store in a place with not too high or low temperature, keep awayfrom direct sunlight exposure.

Indications and Usage

Apply enough amount on face by rubbing it outward along the skin texture, gently tap allowing it to absorb

Dosage and Administration

for external use only

Description

Apply enough amount on face by rubbing it outward along the skin texture, gently tap allowing it to absorb

Section 50565-1

Keep out of reach of children.

Section 51727-6

water, butylene glycol, niacinamide, etc.

Section 51945-4

Section 55105-1

Softly covers dark and uneven complexion to create flawless skin.

Section 55106-9

glycerin


Structured Label Content

Indications and Usage (34067-9)

Apply enough amount on face by rubbing it outward along the skin texture, gently tap allowing it to absorb

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

Discontinue use of the product if any of the following symptoms occurred. Consult a dermatologist if the symptoms got worse.

a) If redness, Swelling, Itchiness, Irritation occurred during using.

b) If the above symptoms started to occur when exposed to direct sunlight.

Do not use on skins with wounds, eczema or dermatitis.

Storage instructions

a) Always close the lid after finish using.

b) Store in a safe place away and out of reach of children.

c) Store in a place with not too high or low temperature, keep awayfrom direct sunlight exposure.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

water, butylene glycol, niacinamide, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Softly covers dark and uneven complexion to create flawless skin.

Section 55106-9 (55106-9)

glycerin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)