Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID ed6374a9-4cbd-4037-88d0-ac01d1f00a29

Route

TOPICAL

Published

Effective Date 2017-06-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dimethicone (50 mg)

Inactive Ingredients

Aloe Vera Leaf Water Cetyl Alcohol Diethanolamine Cetyl Phosphate Ethylhexylglycerin Glyceryl Monostearate C13-14 Isoparaffin Laureth-7 Ethylhexyl Palmitate Peg-100 Stearate Phenoxyethanol Polyacrylamide (10000 Mw) Polysorbate 20 Propylene Glycol Stearic Acid .alpha.-tocopherol Acetate, Dl-

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2016-02-01

Description

Active ingredient Dimethicone 5.0%

Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use on -deep or puncture wounds -animal bites

-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 help relieve chapped or cracked skin

Dosage and Administration

Directions

-apply cream liberally as needed.

Description

Active ingredient Dimethicone 5.0%

Section 44425-7

Other information

-protect from freezing avoid excessive heat

Section 50565-1

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients Aloe Barbadensis Leaf (Aloe Vera Gel)

Juice, Aqua (Deionized Water), Cetyl Alcohol, DEA-Cetyl

Phosphate, Ethylhexylglycerin, Glyceryl Stearate, Glyceryl

Stearate SE, C13-14 Isoparaffin, Laureth-7, Octyl Palmitate,

PEG-100 Stearate, Phenoxyethanol, Polyacrylamide,

Polysorbate-20, Propylene Glycol, Stearic Acid, Tocopheryl

Acetate (Vitamin E).

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

Active ingredient

Dimethicone 5.0%

Structured Label Content

Indications and Usage (34067-9)

Uses

-temporarily protects and help relieve chapped or cracked skin

Dosage and Administration (34068-7)

Directions

-apply cream liberally as needed.

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use on -deep or puncture wounds -animal bites

-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

-protect from freezing avoid excessive heat

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients Aloe Barbadensis Leaf (Aloe Vera Gel)

Juice, Aqua (Deionized Water), Cetyl Alcohol, DEA-Cetyl

Phosphate, Ethylhexylglycerin, Glyceryl Stearate, Glyceryl

Stearate SE, C13-14 Isoparaffin, Laureth-7, Octyl Palmitate,

PEG-100 Stearate, Phenoxyethanol, Polyacrylamide,

Polysorbate-20, Propylene Glycol, Stearic Acid, Tocopheryl

Acetate (Vitamin E).

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Active ingredient

Dimethicone 5.0%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses -temporarily protects and help relieve chapped or cracked skin", "34068-7": "Directions -apply cream liberally as needed.", "34071-1": "Warnings For external use only Do not use on -deep or puncture wounds -animal bites -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", "44425-7": "Other information -protect from freezing avoid excessive heat", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive Ingredients Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, DEA-Cetyl Phosphate, Ethylhexylglycerin, Glyceryl Stearate, Glyceryl Stearate SE, C13-14 Isoparaffin, Laureth-7, Octyl Palmitate, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Propylene Glycol, Stearic Acid, Tocopheryl Acetate (Vitamin E).", "55105-1": "Skin Protectant", "55106-9": "Active ingredient Dimethicone 5.0%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:22.850842 · Updated: 2026-03-14T22:54:46.340416