ICE ANALGESIC- menthol gel

Ice ANALGESIC by

Drug Labeling and Warnings

Ice ANALGESIC by is a Otc medication manufactured, distributed, or labeled by Filo America, Ningbo Pulisi Daily Chemical Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

ICE Analgesic Gel

Net wt 8oz (227g)

DISTRIBUTED BY:

Filo America

P.O. Box 23592

Los  Angeles, CA 90023

Developed in USA, products in PRC

questions or concerns?

1.866.460.0322

ASSURED ICE COLD TOPICAL ANALGESIC GEL 8oz (33992-7994-8)

INGREDIENTS AND APPEARANCE

ICE ANALGESIC 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50438-501
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: 50438-501-01	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	05/05/2015

Labeler - Filo America (943873703)

Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd.		529047265	manufacture(50438-501)