THERACARE MEDICATED CHEST RUB (camphor- synthetic, eucalyptus oil, and menthol ointment

TheraCare Medicated Chest Rub by

Drug Labeling and Warnings

TheraCare Medicated Chest Rub by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, ANICARE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Purpose

Camphor 4.8% Cough suppressant, topical analgesic

Menthol 2.6% Cough suppressant, topical analgesic

Eucalyptus oil 1.2% Cough suppressant

Uses

• Temporarily relieves throat and chest
• cough
• nasal congestion due to common cold
• aching muscles
• minor aches and pains

Warnings

For external use only; avoid contact with eyes.

Do not use

• by mouth
• in nostrils
• on wounds or damaged skin
• with tight bandages

Ask a doctor before use if you have

• asthma
• excessive phlegm (mucus)
• emphysema
• persistent or chronic cough
• cough associated with smoking

When using this product, do not

• heat
• microwave
• use near open flame
• add to hot water or any container where heating water may cause splattering and result in burns
  

Stop use and ask a doctor if

• muscle aches/pain persist more than 7 days or comes back
• cough lasts more than 7 days or comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

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

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (800-222-1222) right away.

Directions

see important warnings under " When using this product"

• children under 2 years of age, ask a doctor before using this product

adults and children 2 years and over:

• rub a thick layer on chest & fractor rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily

Other information

• store at room temperature

Inactive ingredients

cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil

PRINCIPAL DISPLAY PANEL - 113 g

INGREDIENTS AND APPEARANCE

THERACARE MEDICATED CHEST RUB 
camphor (synthetic), eucalyptus oil, and menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.048 g  in 1 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	0.012 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.026 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
CEDAR LEAF OIL (UNII: BJ169U4NLG)
NUTMEG OIL (UNII: Z1CLM48948)
THYMOL (UNII: 3J50XA376E)
TURPENTINE OIL (UNII: C5H0QJ6V7F)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-200-01	1 in 1 BOX	01/01/2022
1		113 g in 1 JAR; 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	01/01/2022

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Private Limited		726025211	manufacture(71101-200)