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.

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.

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.

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

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

Mentol, Camphor (synthetic)

info@quimicashandal.com

1620

1595

Principal

1606

Principal

1594

Principal

1602

Principal

1600

Principal

1598

Principal

1612

Principal

1609

Principal

1610

Principal

1605

Principal

1611

Principal

1599

Principal

1601

Principal

RAYO ACTIVE HEAT
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1610
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	1 g in 1 g
WATER (UNII: 059QF0KO0R)	1 g in 1 g
MINERAL OIL (UNII: T5L8T28FGP)	1 g in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN)	1 g in 1 g
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)	1 g in 1 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1610-1	1 in 1 BOX	11/01/2023
1		4 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/01/2023

RAYO ACTIVE HEAT
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1595
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	1 g in 1 g
WATER (UNII: 059QF0KO0R)	1 g in 1 g
MINERAL OIL (UNII: T5L8T28FGP)	1 g in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN)	1 g in 1 g
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)	1 g in 1 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1595-1	1 in 1 BOX	11/01/2023
1		113.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/01/2023

RAYO ACTIVE HEAT
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1599
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	1 g in 1 g
WATER (UNII: 059QF0KO0R)	1 g in 1 g
MINERAL OIL (UNII: T5L8T28FGP)	1 g in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN)	1 g in 1 g
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)	1 g in 1 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1599-1	1 in 1 BOX	11/01/2023
1		113.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/01/2023

RAYO ACTIVE ICE
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1600
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	1 g in 1 g
WATER (UNII: 059QF0KO0R)	1 g in 1 g
TROLAMINE (UNII: 9O3K93S3TK)	1 g in 1 g
ISOPROPYL ALCOHOL (UNII: ND2M416302)	1 g in 1 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	1 g in 1 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	1 g in 1 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1600-1	1 in 1 BOX	11/01/2023
1		226.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	11/01/2023

RAYO BREATH CHAMOMILE
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1620
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
TURPENTINE (UNII: XJ6RUH0O4G)	1 g in 1 g
EUCALYPTOL (UNII: RV6J6604TK)	1 g in 1 g
PETROLATUM (UNII: 4T6H12BN9U)	1 g in 1 g
CHAMOMILE (UNII: FGL3685T2X)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1620-1	1 in 1 BOX	11/01/2023
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	11/01/2023

RAYO ACTIVE ICE
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1594
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	1 g in 1 g
WATER (UNII: 059QF0KO0R)	1 g in 1 g
TROLAMINE (UNII: 9O3K93S3TK)	1 g in 1 g
ISOPROPYL ALCOHOL (UNII: ND2M416302)	1 g in 1 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	1 g in 1 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	1 g in 1 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1594-1	1 in 1 BOX	11/01/2023
1		113.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	11/01/2023

RAYO BREATH MENTHOL
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1605
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
TURPENTINE (UNII: XJ6RUH0O4G)	1 g in 1 g
EUCALYPTOL (UNII: RV6J6604TK)	1 g in 1 g
PETROLATUM (UNII: 4T6H12BN9U)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1605-1	1 in 1 BOX	11/01/2023
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	11/01/2023

RAYO BREATH MENTHOL
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1611
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
TURPENTINE (UNII: XJ6RUH0O4G)	1 g in 1 g
EUCALYPTOL (UNII: RV6J6604TK)	1 g in 1 g
PETROLATUM (UNII: 4T6H12BN9U)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1611-1	1 in 1 BOX	11/01/2023
1		4 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	11/01/2023

RAYO BREATH CHAMOMILE
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1612
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
TURPENTINE (UNII: XJ6RUH0O4G)	1 g in 1 g
EUCALYPTOL (UNII: RV6J6604TK)	1 g in 1 g
PETROLATUM (UNII: 4T6H12BN9U)	1 g in 1 g
CHAMOMILE (UNII: FGL3685T2X)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1612-1	1 in 1 BOX	11/01/2023
1		4 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	11/01/2023

RAYO POWER ICE HEAT DUAL ACTION
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1602
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	1 g in 1 g
WATER (UNII: 059QF0KO0R)	1 g in 1 g
TROLAMINE (UNII: 9O3K93S3TK)	1 g in 1 g
ISOPROPYL ALCOHOL (UNII: ND2M416302)	1 g in 1 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	1 g in 1 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1602-1	1 in 1 BOX	11/01/2023
1		80 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/01/2023

RAYO BREATH CHAMOMILE
menthol, camphor ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1606
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
TURPENTINE (UNII: XJ6RUH0O4G)	1 g in 1 g
EUCALYPTOL (UNII: RV6J6604TK)	1 g in 1 g
PETROLATUM (UNII: 4T6H12BN9U)	1 g in 1 g
CHAMOMILE (UNII: FGL3685T2X)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1606-1	1 in 1 BOX	11/01/2023
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/01/2023

RAYO ACTIVE ICE SACHET
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1609
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	1 g in 1 g
WATER (UNII: 059QF0KO0R)	1 g in 1 g
TROLAMINE (UNII: 9O3K93S3TK)	1 g in 1 g
ISOPROPYL ALCOHOL (UNII: ND2M416302)	1 g in 1 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	1 g in 1 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	1 g in 1 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1609-1	1 in 1 BOX	11/01/2023
1		4 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	11/01/2023

RAYO ACTIVE HEAT
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1601
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	1 g in 1 g
WATER (UNII: 059QF0KO0R)	1 g in 1 g
MINERAL OIL (UNII: T5L8T28FGP)	1 g in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN)	1 g in 1 g
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)	1 g in 1 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1601-1	1 in 1 BOX	11/01/2023
1		226.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/01/2023

RAYO ACTIVE ICE
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83033-1598
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	1 g in 1 g
WATER (UNII: 059QF0KO0R)	1 g in 1 g
TROLAMINE (UNII: 9O3K93S3TK)	1 g in 1 g
ISOPROPYL ALCOHOL (UNII: ND2M416302)	1 g in 1 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	1 g in 1 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	1 g in 1 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83033-1598-1	1 in 1 BOX	11/01/2023
1		113.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	11/01/2023

Labeler - Quimicas Handal de Centroamerica SA de CV (850638768)

Registrant - Quimicas Handal de Centroamerica SA de CV (850638768)

Name	Address	ID/FEI	Business Operations
Establishment
Quimicas Handal de Centroamerica SA de CV		850638768	label(83033-1611, 83033-1620, 83033-1594, 83033-1595, 83033-1598, 83033-1599, 83033-1600, 83033-1601, 83033-1602, 83033-1605, 83033-1606, 83033-1609, 83033-1610, 83033-1612) , manufacture(83033-1620, 83033-1594, 83033-1595, 83033-1598, 83033-1599, 83033-1600, 83033-1601, 83033-1602, 83033-1605, 83033-1606, 83033-1609, 83033-1610, 83033-1611, 83033-1612)