MINERAL ICE- menthol gel

MINERAL ICE by

Drug Labeling and Warnings

MINERAL ICE by is a Otc medication manufactured, distributed, or labeled by Voyant Beauty, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

MINERAL ICE

DRUG FACTS

Active Ingredients

Menthol 2%

Purpose

Topical analgesic

Uses

• Temporarily relieves minor aches and pains of muscles and joints associated with:
  
• Arthritis
  
• simple backache
  
• strains
  
• Bruises
  
• sport injuries
  
• sprains
  
• Provides cooling penetrating relief

Warnings

For external use only

Do not use

• With other topical pain relievers
  
• With heating pads or heating devices

When using this product

• Do not use in or near the yes
  
• Do not apply to wounds or damaged skin
  
• Do not bandage tightly

Stop use and ask a doctor if

• Conditions worsens
  
• Symptoms last more than 7 days or clear up and occur again within a few days
  
• Redness or irritation develops

If pregnant or breast-feeding:

ask a health professional before use.

Keep out of reach of children.

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

Directions

• Clean affected area before applying
  
• Adults and children 2 years of age and older: apply in affected area not more than 3 to 4 times daily
  
• Children under 2 years of age, ask a doctor

Other information

• Store at controlled temperature 20 to 25C (68-77F) in a tightly cleaned container
  
• Do not use, pour, spill or store near heat or open flame

Inactive Ingredients 

ammonium hydroxide, carbomer, cupric sulfate, FD&C Blue No.1, Isopropyl alcohol, magnesium sulfate, purified water, sodium hydroxide, thymol.

Questions/comments?

1-855-328-5258

PRINCIPAL DISPLAY PANEL 3.5 oz (99.2g)

NDC: 0067-2067-35

Original Theraputic

MINERAL

ICE

Greaseless

Net Wt 3.5 oz (99.2 g)

PRINCIPAL DISPLAY PANEL 8 oz (226.8g)

NDC: 0067-2067-08

Original Theraputic

MINERAL

ICE

Greaseless

Net Wt 8 oz (226.8 g)

PRINCIPAL DISPLAY PANEL 16oz (453.6g)

NDC: 0067-2067-16

Original Theraputic

MINERAL

ICE

Greaseless

Net Wt 16 oz (453.6 g)

INGREDIENTS AND APPEARANCE

MINERAL ICE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61047-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61047-202-01	99.2 g in 1 JAR; Type 0: Not a Combination Product	02/10/2016	05/01/2019
2	NDC: 61047-202-02	226.8 g in 1 JAR; Type 0: Not a Combination Product	02/09/2016	05/01/2019
3	NDC: 61047-202-03	453.6 g in 1 JAR; Type 0: Not a Combination Product	02/08/2016	05/01/2019
4	NDC: 61047-202-04	99.2 g in 1 JAR; Type 0: Not a Combination Product	06/01/2019
5	NDC: 61047-202-05	226.8 g in 1 JAR; Type 0: Not a Combination Product	06/01/2019
6	NDC: 61047-202-06	453.6 g in 1 JAR; Type 0: Not a Combination Product	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/08/2016

Labeler - KIK HOLDCO COMPANY INC. (243547333)