WATER DRENCH HYALURONIC HEALING BALM- dimethicone cream

Water Drench Hyaluronic Healing Balm by

Drug Labeling and Warnings

Water Drench Hyaluronic Healing Balm by is a Otc medication manufactured, distributed, or labeled by Peter Thomas Roth Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dimethicone 5%

PURPOSE

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.

INDICATIONS & 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.

WARNINGS

For external use only

WHEN USING

• Do not get into eyes

STOP USE

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

DO NOT USE

Do not use on

• deep or pumcture wounds
• animal bites
• serious burns

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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.

INACTIVE INGREDIENT

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

QUESTIONS

Question or comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WATER DRENCH HYALURONIC HEALING BALM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54031-581
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2.41 g  in 48.19 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
PANTHENOL (UNII: WV9CM0O67Z)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM PHYTATE (UNII: 88496G1ERL)
GLUCOMANNAN (UNII: 36W3E5TAMG)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EUPHORBIA CERIFERA (CANDELILLA) WAX (UNII: WL0328HX19)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SQUALANE (UNII: GW89575KF9)
WATER (UNII: 059QF0KO0R)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54031-581-01	48.19 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2025
2	NDC: 54031-581-02	48.19 g in 1 CARTON; Type 0: Not a Combination Product	12/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/01/2025

Labeler - Peter Thomas Roth Labs, LLC (780458944)