INSTAFLEX PAIN RELIEF CREAM- menthol cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Healthy Directions, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Topical Analgesic  Uses  Temporarily relieves minor aches and pains of muscles and joints associated with  - simple backache - arthritis  - strains  - sprains  - bruises
Authorization status:
OTC monograph not final
Authorization number:
70015-665-01, 70015-665-02, 70015-665-04

INSTAFLEX PAIN RELIEF CREAM- menthol cream

Healthy Directions, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Instaflex Pain Relief Cream

Drug Facts

Active Ingredient

Menthol (1.25%)

Purpose

Topical Analgesic

Uses Temporarily relieves minor aches and pains

of muscles and joints associated with

simple backache

arthritis

strains

sprains

bruises

Warnings

For external use only

Do not use

with a heating pad, may blister skin

on open wounds or damaged skin

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

do not bandage tightly

Stop use and ask a doctor if

skin redness or excessive skin irritation develops

condition worsens or symptoms persist for more than 7 days

symptoms clear up and occur again in a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions Adult and children 12 years of

age and older: Apply to affected area no more

than 3-4 times daily. Children under 12 years

of age: Consult a doctor.

Other information

Keep product at room termperature and

humidity [59-86°F (15-30°C), 40% RH]. Do not freeze. For Lot

Number and Expiration Date, see crimp at end of tube.

Inactive ingredients C13-14 Isoparaffin, Citrus Aurantium

Dulcis (Orange) Oil, Ethylhexlglycerin, Eucalyptus Globulus Oil,

Glyceryl Stearate, Laureth-7, Oxygenated Corn Oil, PEG-100

Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Water

PAIN RELIEVING CREAM

Ins taflex

PAIN RELIEF

Formulated with an

EXCLUSIVE OXYGENATED OIL

FAST RELIEF FOR ARTHRITIS,

JOINT & MUSCLE PAIN

POWERFUL PAIN RELIEF STARTS IN MINUTES,

LASTS FOR HOURS

Deep Penetrating | Fast Acting | Pleasant Smelling | Non-Greasy

CLINICALLY STUDIED | DOCTOR DEVELOPED

Net wt. [2/4] oz ([57/113] g)

INSTAFLEX PAIN RELIEF CREAM

menthol cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 15-6 6 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

12.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Healthy Directions, LLC

C13 -14 ISO PARAFFIN (UNII: E4F12ROE70 )

O RANGE O IL (UNII: AKN3KSD11B)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

LAURETH-7 (UNII: Z9 5S6 G8 20 1)

CO RN O IL (UNII: 8 470 G57WFM)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO LYACRYLAMIDE ( CRO SSLINKED; 0 .0 1-0 .2 MO LE PERCENT BISACRYLAMIDE) (UNII: RHA9 LWJ49 4)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 15-6 6 5-0 2

1 in 1 CARTON

0 1/0 1/20 19

1

57 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:70 0 15-6 6 5-0 4

1 in 1 CARTON

0 1/0 1/20 19

2

113 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:70 0 15-6 6 5-0 1

1 in 1 CARTON

0 6 /10 /20 20

3

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 1/0 1/20 19

Labeler -

Healthy Directions, LLC (150261183)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pure So urce, LLC

0 8 0 354456

ma nufa c ture (70 0 15-6 6 5)

Revised: 6/2020

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