ICE QUAKE ANALGESIC CREAM WHITE- methyl salicylate and menthol cream

ICE QUAKE Analgesic Cream White by

Drug Labeling and Warnings

ICE QUAKE Analgesic Cream White by is a Otc medication manufactured, distributed, or labeled by Southern Sales & Service, Inc., GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Methyl Salicylate 8%

Menthol 2%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

• arthritis
• simple backache
• bruises
• strains
• sprains

Warnings

For external use only.

If pregnant or breast-feeding, ask a health professional before use.

When using this product

• use only as directed
• Avoid contact with eyes and mucous membranes
• do not bandage tightly or use with a heating devices
• do not apply to wounds or damaged skin
• Do not apply to irritated skin

Stop use and ask a doctor if

• condition worsens
• redness is present
• irritation develops
  

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center Immediately.

Directions

Adults and Children 12 Years of Age or Older

• Apply generously to affected area
• Massage into painfil area until thoroughly absorbed into skin
• Repeat as necessary, but no more than 3 to 4 times daily

INACTIVE INGREDIENT

Mineral oil, Propylene glycol, Cetyl stearyl alcohol, Purified water, Ceteareth-6, Stearyl alcohol, PEG-20 Cetyl/Stearyl Ether, Methylparaben, propylparaben.

PRINCIPAL DISPLAY PANEL

Analgesic Cream White

MENTHOL 2%, METHYL SALICYLATE 8%

NET WT 2 OZ (60 g)

Store: At Room Temperature 15° - 30°C (59°- 86°F). Close cap tightly after use.

Distribute By: SSS group, LLC

Pembroke Pines, FL 33332

Questions or Commnets?

Call 800.213.9370

INGREDIENTS AND APPEARANCE

ICE QUAKE ANALGESIC CREAM WHITE 
methyl salicylate and menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69822-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	8.0
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.0

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
CETEARETH-6 (UNII: 2RJS3559D3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69822-300-02	1 in 1 TUBE; Type 0: Not a Combination Product	10/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2016

Labeler - Southern Sales & Service, Inc. (013114906)

Establishment
Name	Address	ID/FEI	Business Operations
Southern Sales & Service, Inc.		013114906	LABEL(69822-300)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	MANUFACTURE(69822-300)