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NDC 72859-0890-02 COOL CURE Pain Relief 40 mg/g Details

COOL CURE Pain Relief 40 mg/g

COOL CURE Pain Relief is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by SDRH Inc. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	72859-0890
Product ID	72859-890_814d1b72-808c-5ee6-e053-2991aa0ad124
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	COOL CURE Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	LIDOCAINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	mg/g
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	SDRH Inc
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 72859-0890-02 (72859089002)

Pricing Information	N/A
NDC Package Code	72859-890-02
Billing NDC	72859089002
Package	1 JAR in 1 BOX (72859-890-02) / 57 g in 1 JAR
Marketing Start Date	2019-01-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d8f6af02-845c-4825-86c0-0a6fa44dbde1 Details

DRUG FACTS:

Active Ingredient:

Lidocaine HCl

Topical Anesthetic

INDICATIONS:

Temporary relief of minor pain.

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, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Camphor, Cetyl Esters, Cetyl Myristoleate, Dimethicone, DMDM Hydantoin, Emu Oil, Ethylhexylglycerin, Ethoxydiglycol, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methyl Gluceth 20, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Pyridoxine HCl (Vitamin B6), Salix Alba (Willow) Bark Extract, Steareth-20, Tocopheryl Acetate (Vitamin E) Triethanolamine.

Package Labeling:

INGREDIENTS AND APPEARANCE

COOL CURE PAIN RELIEF

lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72859-890
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
SHEA BUTTER (UNII: K49155WL9Y)
CETYL ESTERS WAX (UNII: D072FFP9GU)
CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LICORICE (UNII: 61ZBX54883)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PEPPERMINT (UNII: V95R5KMY2B)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
STEARETH-20 (UNII: L0Q8IK9E08)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72859-890-02	1 in 1 BOX	01/22/2019
1		57 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 not final	part348	01/22/2019

Labeler - SDRH Inc (105195732)

Revised: 2/2019

Document Id: 814d1b72-808c-5ee6-e053-2991aa0ad124

Set id: d8f6af02-845c-4825-86c0-0a6fa44dbde1

Version: 2

Effective Time: 20190207