SPL v1
SPL
SPL Set ID c18a29fa-50e8-4080-be75-d4824d6fb1fa
Route
TOPICAL
Published
Effective Date 2016-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (3.0 g)
Inactive Ingredients
Water Goat Milk

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: water, goat milk extract, glycerin, butylene glycol, betaine, peg/ppg-17/6 copolymer, piper methysticum leaf/root/stem extract, cetyl ethylhexanoate, 1,2-hexanediol, arctium lappa root extract, phellinus linteus extract, centella asiatica extract, glyceryl stearate, hydrogenated lecithin, phenoxyethanol, portulaca oleracea extract, ethylhexylglycerin, sodium citrate, chamomilla recutita (matricaria) flower extract, rosmarinus officinalis (rosemary) leaf extract, cetearyl alcohol, ceteth-20, cyclopentasiloxane, steareth-20, triethylhexanoin, citric acid, disodium edta, fragrance, sodium hyaluronate, peg-40 hydrogenated castor oil, calcium pantothenate, amylodextrin, maltodextrin, hydrolyzed hyaluronic acid, sodium ascorbyl phosphate, pyridoxine hcl, folic acid, ceramide 3, cholesterol, raffinose, silica, tromethamine, tocopheryl acetate, palmitoyl pentapeptide-4, panthenol

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: water, goat milk extract, glycerin, butylene glycol, betaine, peg/ppg-17/6 copolymer, piper methysticum leaf/root/stem extract, cetyl ethylhexanoate, 1,2-hexanediol, arctium lappa root extract, phellinus linteus extract, centella asiatica extract, glyceryl stearate, hydrogenated lecithin, phenoxyethanol, portulaca oleracea extract, ethylhexylglycerin, sodium citrate, chamomilla recutita (matricaria) flower extract, rosmarinus officinalis (rosemary) leaf extract, cetearyl alcohol, ceteth-20, cyclopentasiloxane, steareth-20, triethylhexanoin, citric acid, disodium edta, fragrance, sodium hyaluronate, peg-40 hydrogenated castor oil, calcium pantothenate, amylodextrin, maltodextrin, hydrolyzed hyaluronic acid, sodium ascorbyl phosphate, pyridoxine hcl, folic acid, ceramide 3, cholesterol, raffinose, silica, tromethamine, tocopheryl acetate, palmitoyl pentapeptide-4, panthenol

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

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