SPL v4
SPL
SPL Set ID 27be84c1-0227-41ca-beb6-3855eff77e41
Route
TOPICAL
Published
Effective Date 2024-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (2 g)
Inactive Ingredients
Water Medium-chain Triglycerides Sucralfate Croton Lechleri Resin Glycerin Royal Jelly Honey Withania Somnifera Flower Nelumbo Nucifera Whole Polyglyceryl-3 Methylglucose Distearate Alkyl (c12-15) Benzoate Glyceryl Monostearate Shea Butter Polyacrylamide (1500 Mw) C13-14 Isoparaffin Laureth-7 Cocoa Butter Cetyl Alcohol Rosa Moschata Seed Oil Yeast .beta.-d-glucan Saccharomyces Lysate .alpha.-tocopherol Acetate Dmdm Hydantoin Panthenol Diazolidinyl Urea Edetate Trisodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-15

Description

Dimethicone 2%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Dimethicone 2%

Uses

Temporarily protects and helps relieve chapped or cracked skin

Section 42229-5

Questions?Call 1-800-551-2345 or visit www.jafra.com

Warning

For external use only

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 in a few days

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply as needed

Product Label

Active Ingredient

Dimethicone 2%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Polyglyceryl-3 Methylglucose Distearate, C12-15 Alkyl Benzoate, Glyceryl Stearate, Butyrospermum Parkii (Shea) Butter, Glycerin, Theobroma Cacao (Cocoa) Seed Butter, Cetyl Alcohol, Rosa Moschata Seed Oil, Polyacrylamide, Aluminum Sucrose Octasulfate, Croton Lechleri Resin Extract, Tocopheryl Acetate, C13-14 Isoalkane, DMDM Hydantoin, Panthenol, Diazolidinyl Urea, Laureth-7, Trisodium EDTA, Honey, Royal Jelly Powder, Withania Somnifera Extract, Beta-Glucan, Nelumbo Nucifera Extract, Saccharomyces Lysate Extract


Structured Label Content

Uses

Temporarily protects and helps relieve chapped or cracked skin

Section 42229-5 (42229-5)

Questions?Call 1-800-551-2345 or visit www.jafra.com

Purpose

Skin protectant

Warning

For external use only

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 in a few days

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply as needed

Product Label (Product label)

Active Ingredient (Active ingredient)

Dimethicone 2%

Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, Polyglyceryl-3 Methylglucose Distearate, C12-15 Alkyl Benzoate, Glyceryl Stearate, Butyrospermum Parkii (Shea) Butter, Glycerin, Theobroma Cacao (Cocoa) Seed Butter, Cetyl Alcohol, Rosa Moschata Seed Oil, Polyacrylamide, Aluminum Sucrose Octasulfate, Croton Lechleri Resin Extract, Tocopheryl Acetate, C13-14 Isoalkane, DMDM Hydantoin, Panthenol, Diazolidinyl Urea, Laureth-7, Trisodium EDTA, Honey, Royal Jelly Powder, Withania Somnifera Extract, Beta-Glucan, Nelumbo Nucifera Extract, Saccharomyces Lysate Extract


Advanced Ingredient Data


Raw Label Data

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