SPL v1
SPL
SPL Set ID c2615be3-976c-4331-8851-a3812c89e932
Route
TOPICAL
Published
Effective Date 2016-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (0.6 g)
Inactive Ingredients
Goat Milk Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-12-01

Description

Active ingredients: Dimethicone 1.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active ingredients: Dimethicone 1.0%

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: Dimethicone 1.0%

Inactive Ingredient

Inactive ingredients: goat milk extract, cyclopentasiloxane, water, glycerin, propanediol, niacinamide, piper methysticum leaf/root/stem extract, dimethicone/peg-10/15 crosspolymer, polyquaternium-51, sodium chloride, titanium dioxide, arctium lappa root extract, centella asiatica extract, phellinus linteus extract, hydrogenated lecithin, portulaca oleracea extract, fragrance, sodium citrate, chamomilla recutita (matricaria) flower extract, rosmarinus officinalis (rosemary) leaf extract, ethylhexylglycerin, phenoxyethanol, adenosine, triethoxycaprylylsilane, peg-10 dimethicone, peg-9 polydimethylsiloxyethyl dimethicone, calcium pantothenate, amylodextrin, maltodextrin, butylene glycol, hydrolyzed hyaluronic acid, sodium ascorbyl phosphate, pyridoxine hcl, folic acid, ceramide 3, cholesterol, raffinose, silica, tromethamine, palmitoyl pentapeptide-4, panthenol, 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: Dimethicone 1.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: goat milk extract, cyclopentasiloxane, water, glycerin, propanediol, niacinamide, piper methysticum leaf/root/stem extract, dimethicone/peg-10/15 crosspolymer, polyquaternium-51, sodium chloride, titanium dioxide, arctium lappa root extract, centella asiatica extract, phellinus linteus extract, hydrogenated lecithin, portulaca oleracea extract, fragrance, sodium citrate, chamomilla recutita (matricaria) flower extract, rosmarinus officinalis (rosemary) leaf extract, ethylhexylglycerin, phenoxyethanol, adenosine, triethoxycaprylylsilane, peg-10 dimethicone, peg-9 polydimethylsiloxyethyl dimethicone, calcium pantothenate, amylodextrin, maltodextrin, butylene glycol, hydrolyzed hyaluronic acid, sodium ascorbyl phosphate, pyridoxine hcl, folic acid, ceramide 3, cholesterol, raffinose, silica, tromethamine, palmitoyl pentapeptide-4, panthenol, 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)