Search by Drug Name or NDC

NDC 72613-0275-04 MENTHOGEL Pain Relief 26 mg/mL Details

MENTHOGEL Pain Relief 26 mg/mL

MENTHOGEL Pain Relief is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Care Code, Inc. The primary component is MENTHOL.

Product Information

NDC	72613-0275
Product ID	72613-275_785a0713-4fc4-ec41-e053-2991aa0aab5d
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	MENTHOGEL Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	26
Active Ingredient Units	mg/mL
Substance Name	MENTHOL
Labeler Name	Care Code, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 72613-0275-04 (72613027504)

Pricing Information	N/A
NDC Package Code	72613-275-04
Billing NDC	72613027504
Package	118 mL in 1 JAR (72613-275-04)
Marketing Start Date	2018-09-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4d8cb205-42a3-45f0-a0e2-f677938fe182 Details

Drug Facts:

Active ingredient

Menthol 2.60%

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains

Warnings:

For external use only.
Avoid contact with eyes.
If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.
Do not apply to wounds or damaged skin.
Do not bandage tightly.

If pregnant or breast-feeding,

contact physician prior to use.

Directions:

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
Children under two-years of age: Consult a physician..

Additional Information:

Store at room temperature.

Other Ingredients

Acrylates Copolymer, Aqua (Deionized Water), Caprylyl Glycol, Chamomilla Recutita (Chamomile) Extract, Isopropyl Myristate, Melaleuca Alternifolia (Tea Tree) Oil, Olea Europaea (Olive) Oil, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Prunus Amygdalus Dulcis (Almond) Oil, Triethanolamine, FD&C Yellow #5.

Package Labeling:

INGREDIENTS AND APPEARANCE

MENTHOGEL PAIN RELIEF

menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72613-275
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	26 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHAMOMILE (UNII: FGL3685T2X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TEA TREE OIL (UNII: VIF565UC2G)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALMOND (UNII: 3Z252A2K9G)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72613-275-04	118 mL in 1 JAR; Type 0: Not a Combination Product	09/14/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/14/2018

Labeler - Care Code, Inc (115615985)

Revised: 10/2018

Document Id: 785a0713-4fc4-ec41-e053-2991aa0aab5d

Set id: 4d8cb205-42a3-45f0-a0e2-f677938fe182

Version: 2

Effective Time: 20181016