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NDC 71101-0218-01 TheraCare Pain Relieving Muscle Vanishing Scent 25 mg/g Details

TheraCare Pain Relieving Muscle Vanishing Scent 25 mg/g

TheraCare Pain Relieving Muscle Vanishing Scent is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Veridian Healthcare. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	71101-0218
Product ID	71101-218_d8c32445-eda1-4181-e053-2a95a90a7a5a
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 Pain Relieving Muscle Vanishing Scent
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL, UNSPECIFIED FORM
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	25
Active Ingredient Units	mg/g
Substance Name	MENTHOL, UNSPECIFIED FORM
Labeler Name	Veridian Healthcare
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71101-0218-01 (71101021801)

Pricing Information	N/A
NDC Package Code	71101-218-01
Billing NDC	71101021801
Package	1 TUBE in 1 CARTON (71101-218-01) / 57 g in 1 TUBE
Marketing Start Date	2021-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d166aa21-479b-6265-e053-2995a90aca53 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 2.5%

Purpose

Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

simple backache
arthritis
strains
bruises
sprains

Warnings

For external use only.

Do not use

on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over the affected area

When using this product

use only as directed
avoid contact with eyes or mucous membranes
do not bandage tightly

Stop use and ask a doctor if

excessive skin irritation occurs
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: consult physician

Other information

store at 20° to 25°C (68° to 77°F)

Do not use if tube seal under cap is broken

Inactive ingredients

benzyl alcohol, butylated hydroxtoluene, camphor, carbomer, DMDM hydantoin, edetate disodium, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

Questions?

call 866-326-1313 (toll-free)

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

INGREDIENTS AND APPEARANCE

THERACARE PAIN RELIEVING MUSCLE VANISHING SCENT

menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71101-218
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	25 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARBOMER 940 (UNII: 4Q93RCW27E)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ISOCETETH-20 (UNII: O020065R7Z)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71101-218-01	1 in 1 CARTON	11/01/2021
1		57 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 not final	part348	11/01/2021

Labeler - Veridian Healthcare (830437997)

Name	Address	ID/FEI	Business Operations
Establishment
ANICARE PHARMACEUTICALS PRIVATE LIMITED		916837425	manufacture(71101-218)

Revised: 2/2022

Document Id: d8c32445-eda1-4181-e053-2a95a90a7a5a

Set id: d166aa21-479b-6265-e053-2995a90aca53

Version: 2

Effective Time: 20220224