ICY COOL MAXIMUM STRENGTH- menthol gel

Icy Cool by

Drug Labeling and Warnings

Icy Cool by is a Otc medication manufactured, distributed, or labeled by C.D.M.A. Inc., NATURAL ESSENTIALS, INC., NATURAL ESSENTIALS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

Natural Menthol 5.5%

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain associated with:

• arthritis,
• simple backache
• muscle strains
• sprains
• bruises
• cramps

Warnings

For external use only

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged, broken or irritated skin
• a transient burning sensation may occur upon application but generally disappears in several days.

Stop use and ask a doctor if

• condition worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable

• keep away from fire of flame

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

Keep out of reach of children. If swallowed, get medical help of contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

• apply generously to affected area
• message into painful area until thoroughly absorbed into skin
• repeat as necessary, but no more than 3 to 4 times daily

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Children 12 years or younger, ask a doctor

Inactive ingredients –

Aloe Barbadensis Leaf Extract, Carbomer, FD&C Blue #1, Glycerine USP, Ilex Paraguariensis Extract, Isopropyl Alcohol USP, Camphor, Propylene Glycol USP, Methyl Paraben, Purified Water, Silicon Dioxide, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine

Principal Display Panel - 3 oz. Roll on Label

QC Quality Choice

NDC: 63868-632-82

*Compare to BIOFREEZE®
Pain Relieving Gel

Maximum Strength

Icy CoolTM with aloe

Pain Relieving Roll-On

Natural Menthol 5.5% | Topical Analgesic

Relief From Aches and Pains Associated with Strains, Sprains, Backaches, Bruises and Arthritis

1 Roll-on 3oz./89mL.

INGREDIENTS AND APPEARANCE

ICY COOL   MAXIMUM STRENGTH
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-632
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	55 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-632-82	89 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2013

Labeler - C.D.M.A. Inc. (011920774)

Registrant - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS INC.		947484713	MANUFACTURE(63868-632)