ICY FREEZE- menthol gel 
NATURAL ESSENTIALS, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ICY FREEZE COOLING PAIN RELIEF

Drug Facts

Active ingredient

Menthol 3.5%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains associated with:

Warnings

Do not use

  • With heating pad or device
  • With creams, ointments, sprays or liniments
  • On wounds, damaged skin or irritated skin

Ask a doctor before use if you

  • Have sensitive skin
  • Are pregnant or breastfeeding

When using this product

  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days
  • Irritation develops

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

Directions Adults/Children 2 years and older:

  • Apply to the affected area not more than 3 to 4 times daily; Rub into skin until solution vanishes

Children under 2 years old:

  • Application should be supervised by an adult.

Other information

  • Replace cap after use
  • Store in a cool, dry place.

Non-medicinal ingredients Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-alpha Tocopheryl acetate, Purified Water, dl-Camphor, Carbomer, Isopropyl alcohol, Methylparaben, Triethanolamine.

MADE IN USA for Healer Health LLC

Zionsville, Indiana 46077 TM Reg'd 85140-L

ICYFREEZE.COM

Principal Display Panel - Icy Freeze 3oz Gel Pump

FREEZES PAIN

THERAPUTIC PAIN RELIEF

Greaseless and stain free with Aloe, Vitamin E and Ilex

NATURAL INGREDIENTS • SOOTHING MENTHOL • VANISHING SCENT

ICY FREEZE

COOLING PAIN RELIEF

FOR TENDONITIS, ARTHRITIS, SPRAINS AND STRAINS

GEL

4 FL OZ (120 mL)

Principal Display Panel - Icy Freeze 3oz Gel Pump

Principal Display Panel - Icy Freeze 3oz Roll On

FREEZES PAIN

THERAPUTIC PAIN RELIEF

Greaseless and stain free with Aloe, Vitamin E and Ilex

NATURAL INGREDIENTS • SOOTHING MENTHOL • VANISHING SCENT

ICY FREEZE

COOLING PAIN RELIEF

FOR TENDONITIS, ARTHRITIS, SPRAINS AND STRAINS

ROLL-ON

3 FL OZ (90 mL)

Principal Display Panel - Icy Freeze 3oz Roll On
ICY FREEZE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-165
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-165-031 in 1 BOTTLE, WITH APPLICATOR12/01/2017
190 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:66902-165-041 in 1 BOTTLE, PUMP12/01/2017
2120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2017
Labeler - NATURAL ESSENTIALS, INC. (947484713)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-165)

Revised: 12/2017
Document Id: a6e37537-90e9-4edd-9a7c-cf0b91deba1c
Set id: 41b2e9a0-818d-4188-8c9d-8ff7c0d0519b
Version: 1
Effective Time: 20171201
 
NATURAL ESSENTIALS, INC.