NEPTUNE ICE PATCH- lidocaine, menthol, camphor, and dimethicone patch patch

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

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Active ingredient:
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Neptune Products L.L.C.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Anesthetic Topical Analgesic Topical Analgesic Skin Conditioner For the temporary relief of joint pain and muscle pain associated with: - Arthritis - Backache - Cramps - Discomfort - Neckache - Soreness - Sprains - Strains
Authorization status:
OTC monograph not final
Authorization number:
72594-1847-8

NEPTUNE ICE PATCH- lidocaine, menthol, camphor, and dimethicone patch patch

Neptune Products L.L.C.

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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Neptune Ice Patch

DRUG FACTS

Methemoglobinemia

Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all

patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase

deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants

under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more

susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in

these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after

exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood.

Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more

serious central nervous system and cardiovascular adverse effects, including seizures, coma,

arrhythmias, and death. Discontinue lidocaine-containing products and any other oxidizing agents.

Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen

therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange

transfusion, or hyperbaric oxygen.

Active Ingredient

Lidocaine 4%

Purpos e

Topical Anesthetic

Active Ingredient

Menthol 1%

Purpos e

Topical Analgesic

Active Ingredient

Camphor 3%

Purpos e

Topical Analgesic

Active Ingredient

Dimethicone 3%

Purpos e

Skin Conditioner

Us es :

For the temporary relief of joint pain and muscle pain associated with:

Arthritis

Backache

Cramps

Discomfort

Neckache

Soreness

Sprains

Strains

Warnings

For External Use Only

Flammable

Keep away from excessive heat or open flame

Do Not Use

On damaged or irritated skin

With a bandage or heating pad

If you are allergic to any ingredients in this product

Other than as directed

When Using This Product

Avoid contact with the eyes

Stop Use and Ask a Doctor If

Condition worsens

Excessive skin irritation develops

Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

If You Are Pregnant or Breast Feeding

Ask a health professional before use

Keep Out of Reach of Children

If ingested, seek medical help or contact a Poison Control Center immediately

Directions

Adults and Children 12 years of Age and Older:

Clean and dry the affected area

Apply product directly to your skin, up to 4 times daily

Apply product directly to your skin, up to 4 times daily

Other Information

Store in a cool, dry place with lid tightly closed

Inactive Ingredients

Aloe Barbadensls Leaf Extract, Alcohol, Arnlca Montana Flower Extract, Boswellia Serrata Extracl

Butylene Glycol Cellulose Gum Dihydroxyaluminum Aminoecstete, Blycerin, lsopropyl Myristate,

Msttwlsulfonylmethene, Partially Neutralized Polyacrylate, Phenoxvethanol, Polvsorbate 80, Porvvinyl

Pyrrolidone, Propylene Glycol, Tartaric Acid, Tetrasodium EDTA, Water.

Questions or Comments?

Info@neptuneice.cool

Principal Display Panel

NEPTUNE ICE PATCH

lidocaine, menthol, camphor, and dimethicone patch patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7259 4-18 47

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAMPHO R ( NATURAL) (UNII: N20 HL7Q9 41) (CAMPHOR (NATURAL) -

UNII:N20 HL7Q9 41)

CAMPHOR (NATURAL)

450 mg in 1 mg

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

450 mg in 1 mg

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

6 0 0 mg in 1 mg

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

MENTHOL

150 mg in 1 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

DIHYDRO XYALUMINUM AMINO ACETATE (UNII: DO250 MG0 W6 )

DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)

PO LYACRYLIC ACID ( 2 50 0 0 0 MW) (UNII: 9 G2MAD7J6 W)

BO SWELLIA SERRATA RESIN O IL (UNII: 5T1XCE6 K8 K)

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

TARTARIC ACID (UNII: W48 8 8 I119 H)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7259 4-18 47-8

2 in 1 BOX

0 4/12/20 19

1

5 in 1 POUCH

1

150 0 0 mg in 1 PATCH; 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 4/12/20 19

Neptune Products L.L.C.

Labeler -

Neptune Products L.L.C. (081502369)

Revised: 8/2019

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