84558-009

84558-009
SPL v1
SPL
SPL Set ID 348662a1-cce4-fe2d-e063-6294a90aa051
Route
CUTANEOUS
Published
Effective Date 2025-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (4 g) Dimethicone (2 g)
Inactive Ingredients
Vanillyl Butyl Ether Carthamus Tinctorius (safflower) Seed Oil Dimethyl Sulfone Dipotassium Glycyrrhizate Edetate Disodium Bisabolol Aqua Caprylic/capric Triglyceride Propanediol Hydrogenated Polyisobutene (450 Mw) Polyglyceryl-3 Methylglucose Distearate Helianthus Annuus (sunflower) Seed Oil Cetearyl Alcohol 1,2-hexanediol Hydroxyacetophenone Polysorbate 80 Xanthan Gum Sodium Hydroxide Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Tocopherol Ginger Polyglyceryl-10 Myristate Carbomer Butyrospermum Parkii (shea) Butter Butylene Glycol Ci 15985 Borneol Melaleuca Alternifolia (tea Tree) Leaf Oil Isohexadecane Sodium Hyaluronate Ci 19140 Alpha-tocopherol Acetate C13-16 Isoparaffin Polyglyceryl-3 Distearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-07

Description

GLYCERIN 4% DIMETHICONE 2%

Purpose

Skin Conditioners


Medication Information

Purpose

Skin Conditioners



Description

GLYCERIN 4% DIMETHICONE 2%

Use

Through gentle massage, it nourishes the skin while also providing the following benefits:

Relieves joint,muscle discomfort, promotes joint repair, relaxes muscles, and alleviates fatigue , muscle soreness.

Section 50565-1

If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.



Section 50566-9

Irritation or rash occurs.



Section 50567-7

Avoid contact with eyes. In case of such contact, rinse well with water. We recommend conducting a 24-hour

patch test before use.



Warnings

For external use only

Directions

After cleansing, take an appropriate amount of the product and evenly apply it to the skin on the neck, shoulders, waist,

legs, and knees. Gently massage.



Do Not Use

If there is a known sensitivity to any of the ingredients.

Damaged or broken skin.

Swallow or ingest .



Other Information

■Store in a cool, dry place.

■Keep away from direct sunlight.

■See bottom panel for expiration date.

Active Ingredient(s)

GLYCERIN 4%

DIMETHICONE 2%

Inactive Ingredients

AQUA, CAPRYLIC/CAPRIC TRIGLYCERIDE,PROPANEDIOL, HYDROGENATED POLYISOBUTENE,

POLYGLYCERYL-3 METHYL GLUCOSE DISTEARATE,HELIANTHUS ANNUUS (SUNFL OWER) SEED OIL,

CETEARYL ALCOHOL, 1, 2-HEXANEDIOL, HYDROXYACETOPHENONE, POLYSORBATE 80,

VANILLYL BUTYL ETHER, C13-16 ISOPARAFFIN, DIPOTASSIUM GLYCYRRHIZATE, POLYGLYCERYL-10

MYRISTATE, SODIUM ACRYL .ATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,

CARBOMER, BISABOL OL, BUTYROSPERMUM PARKII (SHEA) BUTTER, MEL _AL .EUCA ALTERNIFOLIA (TEA

TREE) LEAF OIL, TOCOPHERYL ACETATE, POLYGLYCERYL-3 DISTEARATE, ISOHEXADECANE,

BUTYL .ENE GLYCOL, XANTHAN GUM, SODIUM HYDROXIDE, DISODIUM EDTA, SODIUM

HYALURONATE, TOCOPHEROL, CI 19140, CI 15985

Package Label Principal Display Panel


Structured Label Content

Use

Through gentle massage, it nourishes the skin while also providing the following benefits:

Relieves joint,muscle discomfort, promotes joint repair, relaxes muscles, and alleviates fatigue , muscle soreness.

Section 50565-1 (50565-1)

If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.



Section 50566-9 (50566-9)

Irritation or rash occurs.



Section 50567-7 (50567-7)

Avoid contact with eyes. In case of such contact, rinse well with water. We recommend conducting a 24-hour

patch test before use.



Purpose

Skin Conditioners



Warnings

For external use only

Directions

After cleansing, take an appropriate amount of the product and evenly apply it to the skin on the neck, shoulders, waist,

legs, and knees. Gently massage.



Do Not Use (Do not use)

If there is a known sensitivity to any of the ingredients.

Damaged or broken skin.

Swallow or ingest .



Other Information (Other information)

■Store in a cool, dry place.

■Keep away from direct sunlight.

■See bottom panel for expiration date.

Active Ingredient(s)

GLYCERIN 4%

DIMETHICONE 2%

Inactive Ingredients (Inactive ingredients)

AQUA, CAPRYLIC/CAPRIC TRIGLYCERIDE,PROPANEDIOL, HYDROGENATED POLYISOBUTENE,

POLYGLYCERYL-3 METHYL GLUCOSE DISTEARATE,HELIANTHUS ANNUUS (SUNFL OWER) SEED OIL,

CETEARYL ALCOHOL, 1, 2-HEXANEDIOL, HYDROXYACETOPHENONE, POLYSORBATE 80,

VANILLYL BUTYL ETHER, C13-16 ISOPARAFFIN, DIPOTASSIUM GLYCYRRHIZATE, POLYGLYCERYL-10

MYRISTATE, SODIUM ACRYL .ATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,

CARBOMER, BISABOL OL, BUTYROSPERMUM PARKII (SHEA) BUTTER, MEL _AL .EUCA ALTERNIFOLIA (TEA

TREE) LEAF OIL, TOCOPHERYL ACETATE, POLYGLYCERYL-3 DISTEARATE, ISOHEXADECANE,

BUTYL .ENE GLYCOL, XANTHAN GUM, SODIUM HYDROXIDE, DISODIUM EDTA, SODIUM

HYALURONATE, TOCOPHEROL, CI 19140, CI 15985

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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