VHB - Sof Skin Icy Blue Gel (76436-140)

Manufacturer
Viny Health and Beauty Inc
Effective date
2023-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:17:16

Label at a glance#

ProductICY BLUE
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

PROVIDES TEMPORARY RELIEF OF MINOR ACHES AND PAINS IN MUSCLES AND JOINTS ASSOCIATED WITH SIMPLE BACKACHE, STRAINS, SPRAINS, ARTHRITIS AND SPORTS INJURIES

Dosage and administration

CLEAN SKIN OF ALL OTHER LOTIONS, CREAMS, OINTMENTS, LINIMENT OR SPRAYS. APPLY LIBERALLY TO AFFECTED AREA AND MASSAGE UNTIL GEL IS ABSORBED INTO SKIN. DO NOT APPLY MORE THAN 3 OR 4 TIMES DAILY. NO PROTECTIV COVER NEEDED. DO NOT APPLY TO CHILDREN UNDER 2 YEARS OF AGE.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

MENTHOL BP 1.0% W/W

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

USES

INDICATIONS & USAGE SECTION

PROVIDES TEMPORARY RELIEF OF MINOR ACHES AND PAINS IN MUSCLES AND JOINTS ASSOCIATED WITH SIMPLE BACKACHE, STRAINS, SPRAINS, ARTHRITIS AND SPORTS INJURIES

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY. NOT FOR INTERNAL USE.

USE ONLY AS DIRECTED. AVOID CONTACT WITH EYES OR MUCOUS MEMBRANES. DO NOT APPLY TO OPEN WOUNDS OR DAMAGED SKIN. MAKE SURE SKIN IS CLEAN AND FREE FROM ANY CREAMS, OINTMENTS, SPRAYS OR LINIMINT. DO NOT BANDAGE.

DO NOT USE WITH HEATING PADS OR HEATING DEVICES.

IF CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THEN 7 DAYS OR IF SYMPTOMS DISAPPEAR AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE AND CONSULT A PHYSICIAN. IF YOU HAVE SENSITIVE SKIN, CONSULT A PHYSICIAN BEFORE USE. IF SKIN IRRITATION DEVELOPS, DISCONTINUE USE AND CONSULT A PHYSICIAN. IF YOU ARE PREGNANT OR NURSING A BABY, CONSULT YOUR DOCTOR BEFORE USE. DO NOT USE, STORE, POUR OR SPILL NEAR HEAT OR OPEN FLAME. STORE IN A COOL, DRY PLACE AND KEEP LID TIGHTLY CLOSED.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

CLEAN SKIN OF ALL OTHER LOTIONS, CREAMS, OINTMENTS, LINIMENT OR SPRAYS. APPLY LIBERALLY TO AFFECTED AREA AND MASSAGE UNTIL GEL IS ABSORBED INTO SKIN. DO NOT APPLY MORE THAN 3 OR 4 TIMES DAILY. NO PROTECTIV COVER NEEDED. DO NOT APPLY TO CHILDREN UNDER 2 YEARS OF AGE.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

CARBOMER 940 USP/NF, CAMPHOR BP, PROPYLENE GLYCOL BP, SODIUM METHYL PARABEN BP, SODIUM PROPYL PARABEN BP, DISODIUM EDTA BP, IMID UREA USP/NF, ISOPROPYL ALCOHOL BP, SODIUM HYDROXIDE BP, POLYOXYL 40HCO USP.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sofskin ICY BLUE GEL ANALGESIC GEL 7Oz LabelSofskin ICY BLUE GEL ANALGESIC GEL 7Oz Label

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76436-14076436-140-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1279d8e4-bad7-a208-e063-6394a90a7a77e3ee7694-6d7b-4807-e053-2a95a90a1fd72024-02-28WarningsExact identifier
spl set id: e3ee7694-6d7b-4807-e053-2a95a90a1fd7

Reported adverse events (FAERS/openFDA)#

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