MINERAL ICE- menthol gel 
Voyant Beauty, 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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Formula# 1110-00

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 8 oz (226.8g)

NDC 0316-0226-08

Original Theraputic

MINERAL
ICE

MENTHOL PAIN

RELIEVING GEL


Greaseless
With DEEPCOLD PAIN RELIEVER


Net Wt 8 oz (226.8 g)

8oz wrap label

PRINCIPAL DISPLAY PANEL 16oz (453.6g)

NDC 0316-0226-16

Original Theraputic

MINERAL
ICE

MENTOL PAIN

RELIEVING GEL

Greaseless

With DEEPCOLD Pain Reliever

Net Wt 16 oz (453.6 g)

16oz wrap label

MINERAL ICE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61047-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61047-202-0199.2 g in 1 JAR; Type 0: Not a Combination Product02/10/201603/01/2021
2NDC:61047-202-02226.8 g in 1 JAR; Type 0: Not a Combination Product02/09/201603/01/2021
3NDC:61047-202-03453.6 g in 1 JAR; Type 0: Not a Combination Product02/08/201603/01/2021
4NDC:61047-202-05226.8 g in 1 JAR; Type 0: Not a Combination Product03/01/2019
5NDC:61047-202-06453.6 g in 1 JAR; Type 0: Not a Combination Product03/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/08/2016
Labeler - Voyant Beauty, Inc. (243547333)

Revised: 4/2023
Document Id: fa66f019-6d16-903d-e053-6394a90a1188
Set id: fcc6a38a-0280-4766-b035-e2f0601657d8
Version: 5
Effective Time: 20230428
 
Voyant Beauty, Inc.