Ptr - Water Drench Hyaluronic Healing Balm (otc)

Ptr - Water Drench Hyaluronic Healing Balm (otc)
SPL v2
SPL
SPL Set ID 3f789176-1d80-d146-e063-6294a90a948a
Route
TOPICAL
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (2.41 g)
Inactive Ingredients
Citric Acid C10-18 Triglycerides Panthenol Ethylhexyl Palmitate Glyceryl Stearate Isopropyl Myristate Cetyl Palmitate Sodium Benzoate Glycerin Cetyl Alcohol Sodium Hyaluronate Alpha-tocopherol Acetate Sodium Phytate Glucomannan Trihydroxystearin Ethylhexylglycerin Phenoxyethanol Euphorbia Cerifera (candelilla) Wax Butyrospermum Parkii (shea) Butter Xanthan Gum Sodium Stearoyl Glutamate Squalane Water Theobroma Cacao (cocoa) Seed Butter Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Dimethicone 5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses

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

Helps protect from the drying effects of wind and cold weather.

Dosage and Administration

Directions

  • Apply as needed
  • Massage onto the face as the final step of your skin care routine.
  • Can also be used as a spot treatment for dry patches anywhere on the body.
Description

Dimethicone 5%

Section 50565-1

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

Section 50566-9

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 50567-7
  • Do not get into eyes
Section 50570-1

Do not use on

  • deep or pumcture wounds
  • animal bites
  • serious burns
Section 51727-6

WATER/AQUA/EAU, GLYCERIN, ISOPROPYL MYRISTATE, CETYL ALCOHOL, CETYL PALMITATE, GLYCERYL STEARATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, THEOBROMA CACAO (COCOA) SEED BUTTER, C10-18 TRIGLYCERIDES, SQUALANE, SODIUM HYALURONATE, PANTHENOL, TOCOPHERYL ACETATE, CITRIC ACID, SODIUM STEAROYL GLUTAMATE, XANTHAN GUM, SODIUM PHYTATE, ETHYLHEXYL PALMITATE, SODIUM BENZOATE, POTASSIUM SORBATE, GLUCOMANNAN, ETHYLHEXYLGLYCERIN, TRIHYDROXYSTEARIN, PHENOXYETHANOL

Section 51945-4

Section 53413-1

Question or comments?

Cal tl free 1-800-PTR-SKIN (787-7546)

Section 55105-1

Skin protectant

Uses

  • Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin.
  • Helps protect from the drying effects of wind and cold weather.
Section 55106-9

Dimethicone 5%


Structured Label Content

Indications and Usage (34067-9)

Uses

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

Helps protect from the drying effects of wind and cold weather.

Dosage and Administration (34068-7)

Directions

  • Apply as needed
  • Massage onto the face as the final step of your skin care routine.
  • Can also be used as a spot treatment for dry patches anywhere on the body.
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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 50567-7 (50567-7)
  • Do not get into eyes
Section 50570-1 (50570-1)

Do not use on

  • deep or pumcture wounds
  • animal bites
  • serious burns
Section 51727-6 (51727-6)

WATER/AQUA/EAU, GLYCERIN, ISOPROPYL MYRISTATE, CETYL ALCOHOL, CETYL PALMITATE, GLYCERYL STEARATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, THEOBROMA CACAO (COCOA) SEED BUTTER, C10-18 TRIGLYCERIDES, SQUALANE, SODIUM HYALURONATE, PANTHENOL, TOCOPHERYL ACETATE, CITRIC ACID, SODIUM STEAROYL GLUTAMATE, XANTHAN GUM, SODIUM PHYTATE, ETHYLHEXYL PALMITATE, SODIUM BENZOATE, POTASSIUM SORBATE, GLUCOMANNAN, ETHYLHEXYLGLYCERIN, TRIHYDROXYSTEARIN, PHENOXYETHANOL

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Question or comments?

Cal tl free 1-800-PTR-SKIN (787-7546)

Section 55105-1 (55105-1)

Skin protectant

Uses

  • Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin.
  • Helps protect from the drying effects of wind and cold weather.
Section 55106-9 (55106-9)

Dimethicone 5%


Advanced Ingredient Data


Raw Label Data

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