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NDC 71101-0200-01 TheraCare Medicated Chest Rub .048; .012; .026 g/g; g/g; g/g Details

TheraCare Medicated Chest Rub .048; .012; .026 g/g; g/g; g/g

TheraCare Medicated Chest Rub is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Veridian Healthcare. The primary component is CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL.

Product Information

NDC	71101-0200
Product ID	71101-200_d6e79113-664e-4b12-e053-2a95a90ad1e4
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	TheraCare Medicated Chest Rub
Proprietary Name Suffix	n/a
Non-Proprietary Name	Camphor (synthetic), Eucalyptus oil, and Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	.048; .012; .026
Active Ingredient Units	g/g; g/g; g/g
Substance Name	CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL
Labeler Name	Veridian Healthcare
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71101-0200-01 (71101020001)

Pricing Information	N/A
NDC Package Code	71101-200-01
Billing NDC	71101020001
Package	1 JAR in 1 BOX (71101-200-01) / 113 g in 1 JAR
Marketing Start Date	2022-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d6e789c7-a55a-dc9a-e053-2a95a90a2bdb Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/01/2022

Labeler - Veridian Healthcare (830437997)

Name	Address	ID/FEI	Business Operations
Establishment
ANICARE PHARMACEUTICALS PRIVATE LIMITED		916837425	manufacture(71101-200)

Revised: 1/2022

Document Id: d6e79113-664e-4b12-e053-2a95a90ad1e4

Set id: d6e789c7-a55a-dc9a-e053-2a95a90a2bdb

Version: 1

Effective Time: 20220131