Humphreys Bendito Alcoholado

Manufacturer
Humphreys Pharmacal, Incorporated | American Distilling Inc.
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:41:45

Label at a glance#

ProductHumphreys Bendito Alcoholado
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure12 sections

Indications and uses

Para un alivio temporal de dolores musculares y dolores en las articulaciones asociados con: artritis moretones esguinces tensión achaques de espalda For the temporary relief of minor aches and pains of muscles and joints associated with: arthritis bruises sprains strains simple backache

Dosage and administration

Adultos y niños de 2 años en adelante: Aplique sobre la zona afectada no más de 3 ó 4 veces al dia. Niños menores de 2 años en edad: consulte a un médico. Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Storage and handling

Almacene debajo de 30C / Store below 86F

Label contents#

Full prescribing information#

Ingrediente activo / Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Mentol / Menthol 1.25%

Propósito / Purpose

OTC - PURPOSE SECTION

Analgesia Tópica / Topical Anaglesic

Usos / Uses

INDICATIONS & USAGE SECTION

Para un alivio temporal de dolores musculares y dolores en las articulaciones asociados con:

  • artritis
  • moretones
  • esguinces
  • tensión
  • achaques de espalda

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

  • arthritis
  • bruises
  • sprains
  • strains
  • simple backache

Advertencias / Warnings

WARNINGS SECTION

Para uso externo solamente. Evite el contacto con los ojos o las membranas mucosas. Si la condición empeora o los síntomas persisten por más de 7 dias, o si se aliviany retoman días después, interrumpa el uso del producto y consulte a un médico.

For external use only. Avoid contact with eyes or mucous membranes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

OTC - DO NOT USE SECTION

No use este producto si su piel es sensible al aceite de menta-verde (salicilato de metilo). No aplique a heridas ni a la piel maltratada. No ponga un vendaje muy apretado.
Do not use if skin is sensitive to oil of wintergreen (methylsalicylate). Do not apply to wounds or damaged skin. Do not bandage tightly.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Mantenga fuera del alcance de niños. Si se ingiere, consiga asistencia médica o llame al Centro de Control de Venenos inmediatamente.
Keep out of the reach of children. If swallowed,get medical help or contact a Poison Control Center right away

USER SAFETY WARNINGS SECTION

Inflamable. Mantenga alejado del fuego, chispas y superficies calientes.
Flammable keep away from fire, sparks and heated surfaces.

Instrucciones / Directions

DOSAGE & ADMINISTRATION SECTION

Adultos y niños de 2 años en adelante: Aplique sobre la zona afectada no más de 3 ó 4 veces al dia. Niños menores de 2 años en edad: consulte a un médico.
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Ingredientes inactivos / Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor, eucalyptol, FDC blue #1, FDC yellow #5, isopropyl alcohol, methyl salicylate, and purified water

Otra información / Other information

STORAGE AND HANDLING SECTION

Almacene debajo de 30C / Store below 86F

OTC - QUESTIONS SECTION

Distribuido por / Dist. by:

Humphreys Pharmacal, Inc.
East Hampton, CT 06424
Made in USA

www.humphreysusa.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The labels shown below represent a sample of that currently in use. Additional packaging may also be available.


HUMPHREYS

BENDITO
ALCOHOLADO

Analgesia Tópica   /   Topical Anaglesic


REFRESCA - CALMA - PENETRA


Bendito Label FBBendito Label FB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1370957menthol 1.25 % Topical SolutionPSN5
1370957menthol 12.5 MG/ML Topical SolutionSCD5
1370957menthol 1.25 % Topical SolutionSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0219-0203-802020-12-29C16284748780-19855d018-eb25-cd31-e053-dbdaa90ab51aMonografía / Drug Facts
0219-0203-802019-11-27C16284748780-19855d018-eb25-cd31-e053-dbdaa90ab51aMonografía / Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0219-0203-80Humphreys Bendito Alcoholado237 mL in 1 BOTTLE, PLASTICLIQUID2375

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0219-0203HUMPHREYS BENDITO ALCOHOLADO (MENTHOL) LIQUID [HUMPHREYS PHARMACAL, INCORPORATED]5Legacy NDC, 1 package rows20241211_f3e86cb8-2da5-4f6c-8672-7c600f84a7a0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
mentholACTIVE INGREDIENTL7T10EIP3A2
mentholACTIVE MOIETYL7T10EIP3A2
Camphor (Synthetic)INACTIVE INGREDIENT5TJD82A1ET2
eucalyptolINACTIVE INGREDIENTRV6J6604TK2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1M2
isopropyl alcoholINACTIVE INGREDIENTND2M4163022
methyl salicylateINACTIVE INGREDIENTLAV5U5022Y2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0219-02030219-0203-80

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 · 85 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Camphor (Synthetic)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
2 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MSUSPENSION / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YCAPSULE / ORAL16 mgExact identifier — unii candidate
8 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YPASTE, DENTIFRICE / DENTAL1.1 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YLOZENGE / ORAL53 mgExact identifier — unii candidate
8 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 Blue No. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MELIXIR / ORAL0.15 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / ORAL1 mg/1mlExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, EXTENDED RELEASE / ORAL2.03 mgExact identifier — unii candidate
22 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 Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, COATED / ORAL7.93 mgExact identifier — unii candidate
22 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YDOUCHE / VAGINAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / SUBLINGUAL0.11 mgExact identifier — unii candidate
22 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
8 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
methyl salicylateMETHYL SALICYLATELAV5U5022YTABLET / ORAL10 mgExact identifier — unii candidate
8 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. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / BUCCAL0.11 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MSYRUP / ORAL0.1 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
eucalyptolEUCALYPTOLRV6J6604TKJELLY / NASAL68.5 mgExact identifier — unii candidate
7 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MCAPSULE / ORAL652 mgExact identifier — unii candidate
22 equally ranked IID candidates
eucalyptolEUCALYPTOLRV6J6604TKSOLUTION / DENTALNAExact identifier — unii candidate
7 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
isopropyl alcoholISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
methyl salicylateMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
8 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact 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 Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / ORAL180 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDMOUTHWASH / BUCCALNAExact 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
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
eucalyptolEUCALYPTOLRV6J6604TKDROPS / NASAL0.2 mg/1mlExact identifier — unii candidate
7 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MCONCENTRATE / BUCCALNAExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
eucalyptolEUCALYPTOLRV6J6604TKDROPS / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MPOWDER / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MOINTMENT / TOPICAL0.01 %w/wExact identifier — unii candidate
22 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
ea01879b-980f-4611-a75e-61a1ed8e810af3e86cb8-2da5-4f6c-8672-7c600f84a7a02024-12-09WarningsExact identifier
spl id: ea01879b-980f-4611-a75e-61a1ed8e810a
spl set id: f3e86cb8-2da5-4f6c-8672-7c600f84a7a0

Reported adverse events (FAERS/openFDA)#

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