FDA.reportPublic FDA data

Water Drench Hyaluronic Healing Balm

Manufacturer
Peter Thomas Roth Labs, LLC
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:32:31

Label at a glance#

ProductWater Drench Hyaluronic Healing Balm
Active ingredientDIMETHICONE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5%

OTC - PURPOSE SECTION

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 SECTION

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 SECTION

For external use only

OTC - WHEN USING SECTION

  • Do not get into eyes

OTC - STOP USE SECTION

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

OTC - DO NOT USE SECTION

Do not use on

  • deep or pumcture wounds
  • animal bites
  • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

OTC - QUESTIONS SECTION

Question or comments?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tubetube

CartonCarton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54031-581-01Water Drench Hyaluronic Healing Balm48.19 g in 1 TUBECREAM48.192
54031-581-02Water Drench Hyaluronic Healing Balm48.19 g in 1 CARTONCREAM48.192
54031-581-24Water Drench Hyaluronic Healing Balm7 g in 1 TUBECREAM72

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54031-58154031-581-01, 54031-581-02, 54031-581-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID2968PHW8QPIACT
C10-18 TRIGLYCERIDES43AGM4PHPIIACT
PANTHENOLWV9CM0O67ZIACT
ETHYLHEXYL PALMITATE2865993309IACT
GLYCERYL STEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CETYL PALMITATE5ZA2S6B08XIACT
DIMETHICONE92RU3N3Y1OACTIB
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM HYALURONATEYSE9PPT4THIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM PHYTATE88496G1ERLIACT
GLUCOMANNAN36W3E5TAMGIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EUPHORBIA CERIFERA (CANDELILLA) WAXWL0328HX19IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
SQUALANEGW89575KF9IACT
WATER059QF0KO0RIACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-09-23monthly-update2026-06-03 17:45:08

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Water Drench Hyaluronic Healing BalmDIMETHICONEPeter Thomas Roth Labs, LLC3f789176-1d80-d146-e063-6294a90a948a2026-01-13WarningsExact identifier
ndc (package): 54031-581-24
ndc (package): 54031-581-02
ndc (package): 54031-581-01
ndc (product): 54031-581
ndc11 (package): 54031058124
ndc11 (package): 54031058102
ndc11 (package): 54031058101
spl id: 4848799d-7507-3391-e063-6394a90a5324
spl set id: 3f789176-1d80-d146-e063-6294a90a948a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.