DELSYM NO MESS VAPOR ROLL ON (camphor- natural, eucalyptus oil, and menthol, unspecified form ointment

DELSYM by

Drug Labeling and Warnings

DELSYM by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Camphor 5.3%	Cough suppressant/topical analgesic
Eucalyptus oil 1.3%	Cough suppressant
Menthol 2.8%	Cough suppressant/topical analgesic

Uses

temporarily relieves

• cough due to minor throat and bronchial irritation as may occur with the common cold
• cough to help you sleep
• minor aches and pains of muscles and joints

Warnings

For external use only

Ask a doctor before use if you have

• chronic cough that lasts such as occurs with smoking, asthma, or emphysema
• cough that occurs with too much phlegm (mucus)

When using this product

• do not heat, microwave, or add to hot water or any container where heating water. May cause splattering and result in burns
• do not take by mouth or place in nostrils
• do not bandage tightly
• avoid contact with eyes
• do not apply to wounds or damaged skin

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
• muscle aches and pains worsen, persist for more than 7 days, or clear up and occur again within a few days

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• see important warnings under " When using this product"
• adults and children 2 years of age and older
• for cough, apply a thick layer on the throat and chest
• cover with a warm, dry cloth if desired
• clothing should be loose about throat and chest to help vapors reach the nose and mouth
• for muscle aches and pains, apply to affected area
• use up to three times daily or as directed by a doctor
• children under 2 years: ask a doctor

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

fragrance, glyceryl dibehenate, light mineral oil, octyldodecyl olivate, petrolatum

Questions?

1-866-682-4639

You may also report side effects to this phone number.

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Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 50 g Container Carton

NEW
NDC: 72854-352-01

Delsym ®

NO MESS
VAPOR
ROLL-ON
Cough Suppressant & Topical Analgesic
COUGH RELIEF

100%
Natural
Camphor, Eucalyptus Oil,
Menthol

Ointment

Ages 2+

NET WT 1.76 OZ (50 g)

INGREDIENTS AND APPEARANCE

DELSYM  NO MESS VAPOR ROLL ON
camphor (natural), eucalyptus oil, and menthol, unspecified form ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-352
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	53 mg  in 1 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	13 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	28 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-352-01	1 in 1 CARTON	07/01/2022
1		50 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/01/2022

Labeler - RB Health (US) LLC (081049410)