ICE QUAKE ROLL ON (menthol camphor- natural gel

Ice Quake Roll On by

Drug Labeling and Warnings

Ice Quake Roll On 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 INGREDIENT

Active Ingredients	Purpose
Menthol 3.5%	Topical Analgesic
Camphor 0.2%	Topical Analgesic

INACTIVE INGREDIENT

Carbomer, Propylene Glycol, Methylparaben, Isopropyl Alcohol, Triethanolamine, FD&C Blue #1, Purified Water.

KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN

In case of accidental ingestion, seek professional help and contact a Poison
Control Center inmediately.

WARNINGS

For the external use only. Use only as directed.

• Avoid contact with eyes.
• Do not use with other topical products.
• Do not use with heating device.
• Do not apply to open wounds or damaged skin.

Stop Use

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occurs again within a few days, discontinue use of this product and consults a doctor.in.

Uses

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

DOSAGE & ADMINISTRATION

Adults and children 12 years and older.

• Apply to painful muscles and joints.
• Gently massage thoroughly into affected area.
• Repeat as necessary but no more than 4 times daily

PURPOSE

Topical Analgesic

Other Information:

Store at room temperaturewith cap closed tightly.

Distribute by:

SSS Group, LLC.

Pembroke Pines, FL 33332

www.icequakeonline.com

Questions or Comments?

1 800.213.9370

Ice Quake Roll On

INGREDIENTS AND APPEARANCE

ICE QUAKE ROLL ON 
menthol camphor (natural) gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69822-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g  in 100 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69822-102-03	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	11/01/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
Southern Sales & Service, Inc.		013114906	LABEL(69822-102)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	MANUFACTURE(69822-102)