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NDC 72514-0353-00 InstaSoothe Pain Relief .25; 20 mg/mL; mg/mL Details

InstaSoothe Pain Relief .25; 20 mg/mL; mg/mL

InstaSoothe Pain Relief is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Eco Health, Inc.. The primary component is CAPSAICIN; MENTHOL.

Product Information

NDC	72514-0353
Product ID	72514-353_740731bf-1003-77d6-e053-2a91aa0ac8d0
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	InstaSoothe Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL, CAPSAICIN
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	.25; 20
Active Ingredient Units	mg/mL; mg/mL
Substance Name	CAPSAICIN; MENTHOL
Labeler Name	Eco Health, 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 72514-0353-00 (72514035300)

Pricing Information	N/A
NDC Package Code	72514-353-00
Billing NDC	72514035300
Package	100 mL in 1 TUBE (72514-353-00)
Marketing Start Date	2018-08-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 271a179a-dc9b-4652-8b10-2ab109381793 Details

DRUG FACTS:

Active Ingredient:

Menthol 2.00%

Capsaicin 0.025%

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 open 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/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arcticum Lappa (Burdock) Root Extract, Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Salix Alba (Willow) Bark Extract, Sodium Lauryl Sulfate, Tocopheryl Acetate (Vitamin E), Triethanolamine.

Package Labeling:

INGREDIENTS AND APPEARANCE

INSTASOOTHE PAIN RELIEF

menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72514-353
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72514-353-00	100 mL in 1 TUBE; Type 0: Not a Combination Product	08/20/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/20/2018

Labeler - Eco Health, Inc. (052405711)

Revised: 8/2018

Document Id: 740731bf-1003-77d6-e053-2a91aa0ac8d0

Set id: 271a179a-dc9b-4652-8b10-2ab109381793

Version: 1

Effective Time: 20180822