ARCTIC ICE ANALGESIC- menthol gel

ARCTIC ICE ANALGESIC by

Drug Labeling and Warnings

ARCTIC ICE ANALGESIC 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 1.0%

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

Principle display panel

Arctic Ice

Analgesic Gel

Net Wt. 8 oz. (227g)

INGREDIENTS AND APPEARANCE

ARCTIC ICE ANALGESIC 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22431-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.0 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: 22431-012-01	227 g in 1 JAR; Type 0: Not a Combination Product	12/11/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/11/2015

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(22431-012)