59088-212 Exemax Cream

59088-212 Exemax Cream
SPL v1
SPL
SPL Set ID 38e79055-df84-d314-e063-6394a90ac95f
Route
TOPICAL
Published
Effective Date 2025-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (2 g) Dimethicone (5 g)
Inactive Ingredients
Simmondsia Chinensis (jojoba) Seed Oil Hyaluronate Sodium Ginger Citric Acid .alpha.-tocopherol Acetate, Dl- Ethylhexylglycerin Glycerin Oat Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Phenoxyethanol Water Calcium Pantothenate Centella Asiatica Triterpenoids Lactic Acid Sodium Ascorbyl Phosphate Tetrahexyldecyl Ascorbate Niacinamide Pyridoxine Hcl Sodium Hydroxide Maltodextrin Polyacrylate Crosspolymer-6 Sodium Citrate Bisabolol Arnica Montana Flower Carthamus Tinctorius (safflower) Oleosomes Aluminum Starch Octenylsuccinate Inositol Saccharide Isomerate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-02

Description

Drug Facts

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Drug Facts

Uses

● temporarily protects and helps relieve chapped or cracked skin

● helps protect from the drying effects of wind and cold weather

Warnings

● For external use only

Directions

● apply as needed

Do Not Use On

● deep or puncture wounds

● animal bites

● serious burns

Exemax™ Cream

Manufactured by:

PureTek Corporation


Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Other Information

● Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]

Active Ingredients

Dimethicone 5%

Allantoin 2%

Inactive Ingredients:

Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Avena sativa (Oat) Kernel Flour, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus tinctorius (Safflower) Oleosomes, Centella Asiatica (Asiatic Pennywort) Extract, Citric Acid, DL-Alpha-Tocopheryl Acetate (Vitamin E), Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Inositol, Lactic Acid, Maltodextrin, Niacinamide (Vitamin B3), Phenoxyethanol, Polyacrylate Crosspolymer-6, Pyridoxine HCl (Vitamin B6), Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Citrate, Sodium Hyaluronate, Sodium Hydroxide, Sodium Starch Octenylsuccinate, Tetrahexyldecyl Ascorbate, Zingiber Officinale (Ginger) Root Extract.

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

● temporarily protects and helps relieve chapped or cracked skin

● helps protect from the drying effects of wind and cold weather

Description (34089-3)

Drug Facts

Purpose

Skin Protectant

Warnings

● For external use only

Directions

● apply as needed

Do Not Use On (Do not use on)

● deep or puncture wounds

● animal bites

● serious burns

Exemax™ Cream

Manufactured by:

PureTek Corporation


Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Other Information (Other information)

● Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]

Active Ingredients

Dimethicone 5%

Allantoin 2%

Inactive Ingredients: (Inactive ingredients:)

Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Avena sativa (Oat) Kernel Flour, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus tinctorius (Safflower) Oleosomes, Centella Asiatica (Asiatic Pennywort) Extract, Citric Acid, DL-Alpha-Tocopheryl Acetate (Vitamin E), Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Inositol, Lactic Acid, Maltodextrin, Niacinamide (Vitamin B3), Phenoxyethanol, Polyacrylate Crosspolymer-6, Pyridoxine HCl (Vitamin B6), Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Citrate, Sodium Hyaluronate, Sodium Hydroxide, Sodium Starch Octenylsuccinate, Tetrahexyldecyl Ascorbate, Zingiber Officinale (Ginger) Root Extract.

When Using This Product (When using this product)

● do not get into eyes.

Stop Use and Ask A Doctor If (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

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

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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