ZIHUA EMBROCATION

Manufacturer
Hong Kong Zihua Pharmaceutical Ltd.
Effective date
2014-04-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:02

Label at a glance#

ProductZIHUA EMBROCATION Cooling Pain Relief
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with : ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Dosage and administration

■ Adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily ■ Apply liberally and gently rub into affected area ■ Children under 12 years of age, consult a doctor before using ■ Do not use otherwise than as directed

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 11%

Menthol 15%

Methyl salicylate 15%

Purpose

OTC - PURPOSE SECTION

external analgesic

external analgesic

external analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with:

■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings

WARNINGS SECTION

■ For external use only

■ avoid getting into the eyes or on mucous membranes

■ discontinue use if excessive irritation of the skin develops

When using this product

OTC - WHEN USING SECTION

■ do not apply to wound or damaged skin.

■ do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

■ Pain persists for more than 10 days conditions

■ redness is present

■ conditions affect children under 12 years of age

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

to avoid accidental poisoning. If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily

■ Apply liberally and gently rub into affected area

■ Children under 12 years of age, consult a doctor before using

■ Do not use otherwise than as directed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Eucalyptus oil, FDC Blue No. 1 Al Lake, FDC Red No. 40 Al Lake, lavender oil, mineral oil

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1495457camphor 11 % / menthol 15 % / methyl salicylate 15 % Topical OilPSN1
1495457camphor 0.11 MG/MG / menthol 0.15 MG/MG / methyl salicylate 0.15 MG/MG Topical OilSCD1
1495457camphor 11 % / menthol 15 % / methyl salicylate 15 % Topical OilSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49980-003-012019-11-27C16284748780-19855e2a2-4197-60a7-e053-dbdaa90a05bdDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49980-003-01ZIHUA EMBROCATIONCooling Pain Relief1 in 1 BOXOIL11
49980-003-26ZIHUA EMBROCATIONCooling Pain Relief26 mL in 1 BOTTLE, GLASSOIL261

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49980-003ZIHUA EMBROCATION COOLING PAIN RELIEF (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [HONG KONG ZIHUA PHARMACEUTICAL LTD.]1Legacy NDC, 2 package rows20140421_e1480d87-61ff-4af2-b362-6fe74c636b63.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET1
MENTHOLACTIVE MOIETYL7T10EIP3A1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49980-00349980-003-26, 49980-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 98 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii candidate
37 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
37 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / SUBLINGUALNAExact identifier — unii candidate
28 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDMOUTHWASH / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii candidate
37 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii candidate
37 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOAP / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM / SUBLINGUAL0.07 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, EXTENDED RELEASE / ORAL2.22 mgExact identifier — unii candidate
28 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii candidate
28 equally ranked IID candidates

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
6f8edaf3-ed18-49f4-93fb-e39e191a85cfe1480d87-61ff-4af2-b362-6fe74c636b632014-04-21WarningsExact identifier
spl id: 6f8edaf3-ed18-49f4-93fb-e39e191a85cf
spl set id: e1480d87-61ff-4af2-b362-6fe74c636b63

Reported adverse events (FAERS/openFDA)#

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