SPL v2
SPL
SPL Set ID 3a567ae2-37eb-405d-af36-65cc16d5d9e9
Route
TOPICAL
Published
Effective Date 2016-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (1.0 g)
Inactive Ingredients
Goat Milk Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-12-01

Description

Active ingredients: Niacinamide 2.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active ingredients: Niacinamide 2.0%

Use

Use: helps prevent and relieve chapped or cracked skin

Warnings

Warnings: For external use only

When using this product do not get into eyes

Stop use and ask a doctor if rash occurs

Do not use on - deep puncture wounds - animal bites - serious burns

Keep out of reach of children

Directions

Directions: - clean the skin thoroughly before using - apply in daily skin care routine

Active Ingredient

Active ingredients: Niacinamide 2.0%

Inactive Ingredient

Inactive ingredients: goat milk extract, water, propanediol, dipropylene glycol, methylpropanediol, glycerin, piper methysticum leaf/root/stem extract, diphenyl dimethicone, triethylhexanoin, 1,2-hexanediol, arctium lappa root extract, centella asiatica extract, phellinus linteus extract, chamomilla recutita (matricaria) flower extract, rosmarinus officinalis (rosemary) leaf extract, hydrogenated lecithin, portulaca oleracea extract, phenoxyethanol, tromethamine, ethylhexylglycerin, sodium hyaluronate, xanthan gum, disodium edta, fragrance, polyglyceryl-10 myristate, carbomer, peg-40 hydrogenated castor oil, butylene glycol, calcium pantothenate, amylodextrin, folic acid, maltodextrin, hydrolyzed hyaluronic acid, ceramide 3, cholesterol, raffinose, sodium ascorbyl phosphate, pyridoxine hcl, silica, panthenol, palmitoyl pentapeptide-4, tocopheryl acetate

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Use

Use: helps prevent and relieve chapped or cracked skin

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warnings: For external use only

When using this product do not get into eyes

Stop use and ask a doctor if rash occurs

Do not use on - deep puncture wounds - animal bites - serious burns

Keep out of reach of children

Directions

Directions: - clean the skin thoroughly before using - apply in daily skin care routine

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Niacinamide 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: goat milk extract, water, propanediol, dipropylene glycol, methylpropanediol, glycerin, piper methysticum leaf/root/stem extract, diphenyl dimethicone, triethylhexanoin, 1,2-hexanediol, arctium lappa root extract, centella asiatica extract, phellinus linteus extract, chamomilla recutita (matricaria) flower extract, rosmarinus officinalis (rosemary) leaf extract, hydrogenated lecithin, portulaca oleracea extract, phenoxyethanol, tromethamine, ethylhexylglycerin, sodium hyaluronate, xanthan gum, disodium edta, fragrance, polyglyceryl-10 myristate, carbomer, peg-40 hydrogenated castor oil, butylene glycol, calcium pantothenate, amylodextrin, folic acid, maltodextrin, hydrolyzed hyaluronic acid, ceramide 3, cholesterol, raffinose, sodium ascorbyl phosphate, pyridoxine hcl, silica, panthenol, palmitoyl pentapeptide-4, tocopheryl acetate

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)