Essentials Trial Kit

Essentials Trial Kit
SPL v6
SPL
SPL Set ID 2cef2570-84e3-0b15-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (5 g)
Inactive Ingredients
Sodium Hydroxide Alpha-tocopherol Acetate Aloe Ethylhexyl Palmitate Stearic Acid Caprylyl Glycol Glycerin Edetate Disodium Allantoin Tribehenin Carbomer Interpolymer Type A (55000 Cps) Hexylene Glycol Cetostearyl Alcohol Water Phenoxyethanol Octyldodecyl Behenate Behenyl Erucate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Completed Since 2016-03-18 Until 2021-01-30

Description

Dimethicone 5%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Dimethicone 5%

Uses

Helps relieve, prevent and temporarily protect chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather

Warnings

For external use only

Directions

apply as needed to dry, rough, or problem skin areas, reapply as often as needed

Kit Packet

Do Not Use On

deep or puncture wounds, animal bites, serious burns

Active Ingredient

Dimethicone 5%

Inactive Ingredients

water, ethylhexyl palmitate, glyceryl tribehenate, glycerin, stearic acid, cetearyl alcohol, behenyl erucate, octyldodecyl behenate, caprylyl glycol (and) phenoxyethanol (and) hexylene glycol, tocopheryl acetate, allantoin, carbomer, disodium EDTA, aloe barbadensis leaf juice, sodium hydroxide

When Using This Product

avoid contact with eyes

Stop Use and Ask A Doctor If

condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately


Structured Label Content

Uses

Helps relieve, prevent and temporarily protect chafed, chapped or cracked skin. helps protect from the drying effects of wind and cold weather

Purpose

Skin protectant

Warnings

For external use only

Directions

apply as needed to dry, rough, or problem skin areas, reapply as often as needed

Kit Packet (kit packet)

Do Not Use On (Do not use on)

deep or puncture wounds, animal bites, serious burns

Active Ingredient

Dimethicone 5%

Inactive Ingredients

water, ethylhexyl palmitate, glyceryl tribehenate, glycerin, stearic acid, cetearyl alcohol, behenyl erucate, octyldodecyl behenate, caprylyl glycol (and) phenoxyethanol (and) hexylene glycol, tocopheryl acetate, allantoin, carbomer, disodium EDTA, aloe barbadensis leaf juice, sodium hydroxide

When Using This Product (When using this product)

avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

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