SPL v1
SPL
SPL Set ID d8fa5b99-b9aa-fb14-e053-2a95a90a74d9
Route
TOPICAL
Published
Effective Date 2022-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.1 g) Panthenol (0.01 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-02-27

Description

allantoin, panthenol

Purpose

skin protectant


Medication Information

Purpose

skin protectant

Description

allantoin, panthenol

Use

apply proper amount to the skin, or the enclosed bubble pad, wet it with water, make enough bubbles, massage gently all over the face, and rinse thoroughly with warm water

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4

Warnings

For external use only

1) Please consult your doctor if you experience side effects such as swelling, itching, or reddening on the area where you applied this product

2) Do not apply on wounds or cuts. 3) Do not store where children may reach, and avoid keeping it exposed to direct sunlight.

Directions

for external use only

Active Ingredient

allantoin, panthenol

Inactive Ingredients

ZEA MAYS (CORN) STARCH

SODIUM LAUROYL GLUTAMATE

SODIUM COCOYL GLUTAMATE

MANNITOL

BETAINE

PAPAIN

CELLULOSE GUM

ARTEMISIA VULGARIS EXTRACT

ETHYLHEXYLGLYCERIN

CENTELLA ASIATICA EXTRACT

CENTELLA ASIATICA EXTRACT

BROMELAIN

DISODIUM EDTA

ANGELICA GIGAS ROOT EXTRACT

BLETILLA STRIATA ROOT EXTRACT

PORIA COCOS EXTRACT

ANGELICA TENUISSIMA ROOT EXTRACT

POLYGONATUM OFFICINALE RHIZOME/ROOT EXTRACT

CNIDIUM OFFICINALE ROOT EXTRACT

ECTOIN

BUTYLENE GLYCOL

WATER

1,2-HEXANEDIOL

PEARL POWDER


Structured Label Content

Use

apply proper amount to the skin, or the enclosed bubble pad, wet it with water, make enough bubbles, massage gently all over the face, and rinse thoroughly with warm water

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Purpose

skin protectant

Warnings

For external use only

1) Please consult your doctor if you experience side effects such as swelling, itching, or reddening on the area where you applied this product

2) Do not apply on wounds or cuts. 3) Do not store where children may reach, and avoid keeping it exposed to direct sunlight.

Directions

for external use only

Active Ingredient (Active ingredient)

allantoin, panthenol

Inactive Ingredients (Inactive ingredients)

ZEA MAYS (CORN) STARCH

SODIUM LAUROYL GLUTAMATE

SODIUM COCOYL GLUTAMATE

MANNITOL

BETAINE

PAPAIN

CELLULOSE GUM

ARTEMISIA VULGARIS EXTRACT

ETHYLHEXYLGLYCERIN

CENTELLA ASIATICA EXTRACT

CENTELLA ASIATICA EXTRACT

BROMELAIN

DISODIUM EDTA

ANGELICA GIGAS ROOT EXTRACT

BLETILLA STRIATA ROOT EXTRACT

PORIA COCOS EXTRACT

ANGELICA TENUISSIMA ROOT EXTRACT

POLYGONATUM OFFICINALE RHIZOME/ROOT EXTRACT

CNIDIUM OFFICINALE ROOT EXTRACT

ECTOIN

BUTYLENE GLYCOL

WATER

1,2-HEXANEDIOL

PEARL POWDER


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)