Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID cef19bfb-64fc-4266-afae-5e94f30a3f70
Route
TOPICAL
Published
Effective Date 2017-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (.01 g)
Inactive Ingredients
Water Dicaprylyl Carbonate Glycerin Yellow Wax Cetyl Alcohol Glyceryl Stearate Se Medium-chain Triglycerides Sodium Citrate Ceteth-20 Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Sorbitan Phenoxyethanol Jojoba Oil, Randomized Sodium Benzoate Steareth-20 Helianthus Annuus Seed Wax Citric Acid Monohydrate Ethylhexylglycerin Sodium Gluconate Xanthan Gum Acacia Decurrens Flower Wax Polyglycerin-3 Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-05-28

Description

Active Ingredient Dimethicone 1%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use  •on deep or puncture wounds  •on animal bites  •on serious burns

When using this product  •do not get into eyes

Stop use and ask a doctor if  •condition worsens  •symptoms last more than

7 days or clear up and occur again within a few days

Indications and Usage

Uses

•temporarily protects and helps prevent and relieve chafed, chapped, or cracked skin

•moisturizes and nourishes normal to dry skin to keep the skin feeling smooth and soft

Dosage and Administration

Directions

•apply as needed

Description

Active Ingredient Dimethicone 1%

Section 44425-7

Other information   Store between 32°  F and 85°  F

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a

Poison Control Center immediately.

Section 51727-6

Inactive Ingredients:  Water, Dicaprylyl Carbonate, Glycerin, PEG-8

Beeswax, Cetyl Alcohol, Glyceryl Stearate SE, Caprylic/Capric Triglyceride, Sodium

Citrate, Ceteth-20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sorbitan

Caprylate, Phenoxyethanol, Jojoba Esters, Sodium Benzoate, Steareth-20,

Helianthus Annus (Sunflower) Seed Wax, Citric Acid, Ethylhexylglycerin, Sodium

Gluconate, Xantham Gum, Acacia Decurrens Flower Wax, Polyglycerin-3, Tocopherol

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-800-992-9939 or visit www.tena.us

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active Ingredient

Dimethicone 1%


Structured Label Content

Indications and Usage (34067-9)

Uses

•temporarily protects and helps prevent and relieve chafed, chapped, or cracked skin

•moisturizes and nourishes normal to dry skin to keep the skin feeling smooth and soft

Dosage and Administration (34068-7)

Directions

•apply as needed

Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use  •on deep or puncture wounds  •on animal bites  •on serious burns

When using this product  •do not get into eyes

Stop use and ask a doctor if  •condition worsens  •symptoms last more than

7 days or clear up and occur again within a few days

Section 44425-7 (44425-7)

Other information   Store between 32°  F and 85°  F

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a

Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive Ingredients:  Water, Dicaprylyl Carbonate, Glycerin, PEG-8

Beeswax, Cetyl Alcohol, Glyceryl Stearate SE, Caprylic/Capric Triglyceride, Sodium

Citrate, Ceteth-20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sorbitan

Caprylate, Phenoxyethanol, Jojoba Esters, Sodium Benzoate, Steareth-20,

Helianthus Annus (Sunflower) Seed Wax, Citric Acid, Ethylhexylglycerin, Sodium

Gluconate, Xantham Gum, Acacia Decurrens Flower Wax, Polyglycerin-3, Tocopherol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-800-992-9939 or visit www.tena.us

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

Dimethicone 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)