FDA.reportPublic FDA data

RAYO ACTIVE ICE

Manufacturer
Quimicas Handal de Centroamerica SA de CV
Effective date
2026-01-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:34:32

Label at a glance#

ProductRAYO ACTIVE HEAT
Active ingredientMENTHOL, METHYL SALICYLATE, CAMPHOR (SYNTHETIC)
Label structure22 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 2 years of age and older:
  1. Rub a thick layer well over throat and chest
  2. Use 3 to 4 times daily
  3. Keep clothes loose about throat and chest to help vapors reach nose and mouth
  4. For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily
  • Children under 2 years: do not use.

WARNINGS SECTION

  • For external use only; avoid contact with eyes
  • Ask a doctor before if you have: sensitive skin

Do not use

  • by mouth
  • in nostrils
  • on wounds or damaged skin

When using this product

  • Avoid contact with the ayes or muccus membranes
  • Wash hands after use with cool water
  • Do not microwave

Stop use and ask a doctor if:

  • Cough occurs with too much mucus (phlegm), or if symptoms persist for more than 7 days or clear up and occur again within a few days.

INACTIVE INGREDIENT SECTION

T

INDICATIONS & USAGE SECTION

Directions

Adults and children 2 years of age and older:

Rub a thick layer well over throat and chest
Use 3 to 4 times daily
Keep clothes loose about throat and chest to help vapors reach nose and mouth
For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily

Children under 2 years: do not use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

OTC - PURPOSE SECTION

When applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associated with common cold.

OTC - ACTIVE INGREDIENT SECTION

Mentol, Camphor (synthetic)

OTC - QUESTIONS SECTION

info@quimicashandal.com

1620

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16201620

1595

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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1606

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1594

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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1602

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1600

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1598

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PrincipalPrincipal

1612

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PrincipalPrincipal

1609

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PrincipalPrincipal

1610

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PrincipalPrincipal

1605

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PrincipalPrincipal

1611

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PrincipalPrincipal

1599

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PrincipalPrincipal

1601

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PrincipalPrincipal

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130734474714018GTIN-13: 0734474714018
EAN-13: 0734474714018
GTIN-12: 734474714018
UPC-A: 734474714018
GTIN storage (14 digits): 00734474714018		ADG-1609 Rayo Activo ICE Sachet 4g.jpg
BarcodeEAN-130734474714025GTIN-13: 0734474714025
EAN-13: 0734474714025
GTIN-12: 734474714025
UPC-A: 734474714025
GTIN storage (14 digits): 00734474714025		ADG-1610 Rayo Activo Heat Sachet 4g copy.jpg
BarcodeEAN-130734474714032GTIN-13: 0734474714032
EAN-13: 0734474714032
GTIN-12: 734474714032
UPC-A: 734474714032
GTIN storage (14 digits): 00734474714032		ADG-1594 Rayo Activo ICE 4 Oz.jpg
BarcodeEAN-130734474714049GTIN-13: 0734474714049
EAN-13: 0734474714049
GTIN-12: 734474714049
UPC-A: 734474714049
GTIN storage (14 digits): 00734474714049		ADG-1595 Rayo Activo Heat 4 Oz.jpg
BarcodeEAN-130734474714056GTIN-13: 0734474714056
EAN-13: 0734474714056
GTIN-12: 734474714056
UPC-A: 734474714056
GTIN storage (14 digits): 00734474714056		ADG-1598 Rayo Activo ICE Crema 4Oz.jpg
BarcodeEAN-130734474714063GTIN-13: 0734474714063
EAN-13: 0734474714063
GTIN-12: 734474714063
UPC-A: 734474714063
GTIN storage (14 digits): 00734474714063		ADG-1599 Rayo Activo HEAT Crema 4Oz.jpg
BarcodeEAN-130734474714070GTIN-13: 0734474714070
EAN-13: 0734474714070
GTIN-12: 734474714070
UPC-A: 734474714070
GTIN storage (14 digits): 00734474714070		ADG-1600 Rayo Activo ICE Tubo Crema 8Oz.jpg
BarcodeEAN-130734474714087GTIN-13: 0734474714087
EAN-13: 0734474714087
GTIN-12: 734474714087
UPC-A: 734474714087
GTIN storage (14 digits): 00734474714087		ADG-1601 Rayo Activo HEAT Tubo Crema 8 Oz .jpg
BarcodeEAN-130734474714124GTIN-13: 0734474714124
EAN-13: 0734474714124
GTIN-12: 734474714124
UPC-A: 734474714124
GTIN storage (14 digits): 00734474714124		ADG-1602 Rayo ICE-HEAT Roll-On 80 mL.jpg
BarcodeEAN-130734474714162GTIN-13: 0734474714162
EAN-13: 0734474714162
GTIN-12: 734474714162
UPC-A: 734474714162
GTIN storage (14 digits): 00734474714162		ADG-1611 Rayo Alivio Mentol Sachet 4g.jpg
BarcodeEAN-130734474714179GTIN-13: 0734474714179
EAN-13: 0734474714179
GTIN-12: 734474714179
UPC-A: 734474714179
GTIN storage (14 digits): 00734474714179		ADG-1612 Rayo Alivio Manzanilla Sachet 4g.jpg
BarcodeEAN-130734474714209GTIN-13: 0734474714209
EAN-13: 0734474714209
GTIN-12: 734474714209
UPC-A: 734474714209
GTIN storage (14 digits): 00734474714209		ADG-1605 Rayo Alivio Mentol Unguento Vaporizante 50 g.jpg
BarcodeEAN-130734474714216GTIN-13: 0734474714216
EAN-13: 0734474714216
GTIN-12: 734474714216
UPC-A: 734474714216
GTIN storage (14 digits): 00734474714216		ADG-1606 Rayo Alivio Manzanilla Unguento Vaporizante 50 g (1).jpg
BarcodeEAN-131734474714215GTIN-13: 1734474714215
EAN-13: 1734474714215
GTIN storage (14 digits): 01734474714215		1620.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83033-1594-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1595-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1598-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1599-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1600-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1601-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1602-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1605-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1606-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1609-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1610-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1611-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1612-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1620-12025-05-02C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1594-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1595-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1598-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1599-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1600-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1601-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1602-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1605-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1606-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1609-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1610-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1611-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1612-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1620-12025-01-30C16284748780-12cef2736-a143-d83d-e063-dadaa90ab31f09e4a36b-020a-c5b1-e063-6394a90a3e31

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83033-1594-1RAYO ACTIVE ICE1 in 1 BOXCREAM13
83033-1594-1RAYO ACTIVE ICE113.4 g in 1 TUBECREAM113.43
83033-1595-1RAYO ACTIVE HEAT113.4 g in 1 TUBECREAM113.43
83033-1595-1RAYO ACTIVE HEAT1 in 1 BOXCREAM13
83033-1598-1RAYO ACTIVE ICE113.4 g in 1 TUBECREAM113.43
83033-1598-1RAYO ACTIVE ICE1 in 1 BOXCREAM13
83033-1599-1RAYO ACTIVE HEAT1 in 1 BOXCREAM13
83033-1599-1RAYO ACTIVE HEAT113.4 g in 1 TUBECREAM113.43
83033-1600-1RAYO ACTIVE ICE226.8 g in 1 TUBECREAM226.83
83033-1600-1RAYO ACTIVE ICE1 in 1 BOXCREAM13
83033-1601-1RAYO ACTIVE HEAT226.8 g in 1 TUBECREAM226.83
83033-1601-1RAYO ACTIVE HEAT1 in 1 BOXCREAM13
83033-1602-1RAYO POWER ICE HEAT DUAL ACTION80 g in 1 TUBE, WITH APPLICATORGEL803
83033-1602-1RAYO POWER ICE HEAT DUAL ACTION1 in 1 BOXGEL13
83033-1605-1RAYO BREATH MENTHOL1 in 1 BOXCREAM13
83033-1605-1RAYO BREATH MENTHOL50 g in 1 TUBECREAM503
83033-1606-1RAYO BREATH CHAMOMILE50 g in 1 TUBEOINTMENT503
83033-1606-1RAYO BREATH CHAMOMILE1 in 1 BOXOINTMENT13
83033-1609-1RAYO ACTIVE ICE SACHET1 in 1 BOXCREAM13
83033-1609-1RAYO ACTIVE ICE SACHET4 g in 1 POUCHCREAM43
83033-1610-1RAYO ACTIVE HEAT1 in 1 BOXCREAM13
83033-1610-1RAYO ACTIVE HEAT4 g in 1 POUCHCREAM43
83033-1611-1RAYO BREATH MENTHOL4 g in 1 POUCHCREAM43
83033-1611-1RAYO BREATH MENTHOL1 in 1 BOXCREAM13
83033-1612-1RAYO BREATH CHAMOMILE1 in 1 BOXCREAM13
83033-1612-1RAYO BREATH CHAMOMILE4 g in 1 POUCHCREAM43
83033-1620-1RAYO BREATH CHAMOMILE1 in 1 BOXCREAM13
83033-1620-1RAYO BREATH CHAMOMILE50 g in 1 TUBECREAM503

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
83033-161183033-1611-1
83033-162083033-1620-1
83033-159483033-1594-1
83033-159583033-1595-1
83033-159883033-1598-1
83033-159983033-1599-1
83033-160083033-1600-1
83033-160183033-1601-1
83033-160283033-1602-1
83033-160583033-1605-1
83033-160683033-1606-1
83033-160983033-1609-1
83033-161083033-1610-1
83033-161283033-1612-1

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 103 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE WAXXOF597Q3KYIACT
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
CETYL ALCOHOL936JST6JCNIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
MICROCRYSTALLINE WAXXOF597Q3KYIACT
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
CETYL ALCOHOL936JST6JCNIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
MICROCRYSTALLINE WAXXOF597Q3KYIACT
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
CETYL ALCOHOL936JST6JCNIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
ISOPROPYL ALCOHOLND2M416302IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
TURPENTINEXJ6RUH0O4GIACT
EUCALYPTOLRV6J6604TKIACT
PETROLATUM4T6H12BN9UIACT
CHAMOMILEFGL3685T2XIACT
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
POLYSORBATE 806OZP39ZG8HIACT

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
RAYO ACTIVE ICEMENTHOL, CAMPHORQuimicas Handal de Centroamerica SA de CV09e4a36b-020a-c5b1-e063-6394a90a3e312026-01-22WarningsExact identifier
ndc (package): 83033-1612-1
ndc (package): 83033-1599-1
ndc (package): 83033-1598-1
ndc (package): 83033-1611-1
ndc (package): 83033-1610-1
ndc (package): 83033-1605-1
ndc (package): 83033-1602-1
ndc (package): 83033-1600-1
ndc (package): 83033-1606-1
ndc (package): 83033-1609-1
ndc (package): 83033-1594-1
ndc (package): 83033-1620-1
ndc (package): 83033-1601-1
ndc (package): 83033-1595-1
ndc (product): 83033-1602
ndc (product): 83033-1598
ndc (product): 83033-1605
ndc (product): 83033-1609
ndc (product): 83033-1594
ndc (product): 83033-1612
ndc (product): 83033-1600
ndc (product): 83033-1601
ndc (product): 83033-1595
ndc (product): 83033-1610
ndc (product): 83033-1606
ndc (product): 83033-1620
ndc (product): 83033-1599
ndc (product): 83033-1611
ndc11 (package): 83033159501
ndc11 (package): 83033161101
ndc11 (package): 83033162001
ndc11 (package): 83033160101
ndc11 (package): 83033159401
ndc11 (package): 83033160601
ndc11 (package): 83033160001
ndc11 (package): 83033161201
ndc11 (package): 83033160201
ndc11 (package): 83033161001
ndc11 (package): 83033160901
ndc11 (package): 83033159901
ndc11 (package): 83033159801
ndc11 (package): 83033160501
spl id: 48f80d39-675a-af9d-e063-6294a90a2eed
spl set id: 09e4a36b-020a-c5b1-e063-6394a90a3e31

Reported adverse events (FAERS/openFDA)#

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