Ultra Soothing Formula

Manufacturer: Dermafirm INC.
Effective date: 2018-04-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:55:07

Label at a glance#

ProductUltra Soothing Formula

Active ingredientDIMETHICONE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Dimethicone

INACTIVE INGREDIENT SECTION

Water, Beeswax, etc

OTC - PURPOSE SECTION

Skin Protectant - Soothing, Moisturizing

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

After using toner, apply this lotion on your face.
Gently spread and tap.

WARNINGS SECTION

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71638-0009-1	2021-01-29	C162847	48780-1	ba0f9c33-3783-a910-e053-dadaa90a0b85	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71638-0009-1	Ultra Soothing Formula	200 mL in 1 BOTTLE, PUMP	CREAM	200		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71638-0009	ULTRA SOOTHING FORMULA (DIMETHICONE) CREAM [DERMAFIRM INC.]	1	Legacy NDC, 1 package rows	20180402_68d656e4-9777-4fe2-e053-2a91aa0a9fab.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Ultra Soothing Formula
Dimethicone
WATER
YELLOW WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71638-0009	71638-0009-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
YELLOW WAX	2ZA36H0S2V	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
68d656e4-9778-4fe2-e053-2a91aa0a9fab			68d656e4-9777-4fe2-e053-2a91aa0a9fab	2018-04-01	Warnings	Exact identifier spl id: 68d656e4-9778-4fe2-e053-2a91aa0a9fab spl set id: 68d656e4-9777-4fe2-e053-2a91aa0a9fab

Reported adverse events (FAERS/openFDA)#

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