ICE COLD ANALGESIC- menthol gel

Ice Cold Analgesic by

Drug Labeling and Warnings

Ice Cold Analgesic by is a Otc medication manufactured, distributed, or labeled by Volume Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                   Purpose

Menthol 1.0% ............. Topical Analgesic

PURPOSE

Uses temporarily relieves:

• minor muscle aches and pains

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

DT for your DailyTouch

Ice Cold Analgesic Gel

Gel Frio Antimuscular

DOSAGE & ADMINISTRATION

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 & children 2 years & older: apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.

WARNINGS

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 my mouth or place in nostrils
• apply to wounds or damaged skin
• bandage skin

Consult a doctor and discontinue use: if condition worsens, persists for more than 1 week or tends to recur.

INACTIVE INGREDIENT

Inactive Ingredients

camphor, carbomer, FD&C blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ICE COLD ANALGESIC 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50523-087
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50523-087-01	227 g in 1 PACKAGE; 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	07/10/2015

Labeler - Volume Distributors, Inc. (002029544)

Establishment
Name	Address	ID/FEI	Business Operations
Volume Distributors, Inc.		002029544	manufacture(50523-087)