ARCTIC ICE PAIN RELIEVING- menthol gel

ARCTIC ICE pain relieving by

Drug Labeling and Warnings

ARCTIC ICE pain relieving by is a Otc medication manufactured, distributed, or labeled by Blue Cross Laboratories, Inc., Ningbo Liyuan Daily Chemical Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ARCTIC ICE ANALGESIC GEL

Active Ingredient

Menthol 2.0%

Purpose

Topical Analgesic

Uses

Temporary relief:

minor muscles aches and pains

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with

• smoking
• excessive phlegm
• asthma
• emphysema
• persistent or chronic cough
  

When using this product do not

• heat
• microwave
• add to hot water or any container where healing water may cause splattering and result in burns
• use in eyes or directly on mucous membranes
• take by mouth or place in nostrils
• apply to wounds or damaged skin
• bandage skin
  

Consult a doctor and discontinue use

if condition worsens, persist for more than 1 week or tends to recur

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

For the temporary relief of minor muscle aches and pains

see important warnings under "When using this product"

• not for use on children under 2 years of age
• adults and children 2 years of age and older: apply to painful area and massage until gel is absorbed into the skin, repeat 3 to 4 times daily

Inactive Ingredients

blue 1, camphor, carbomer, isopropyl alcohol, methylchoroisothiazolinone, methuylisothiazoline, sodium hydroxide, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARCTIC ICE PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22431-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22431-014-01	1 in 1 PACKAGE	02/23/2017
1		227 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/23/2017

Labeler - Blue Cross Laboratories, Inc. (008298879)

Registrant - Ningbo Liyuan Daily Chemical Products Co., Ltd (530766098)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd		530766098	manufacture(22431-014)