PHARMACY BEST ICE by New Pride Corp

Drug Details [pdf]

PHARMACY BEST ICE- menthol gel
New Pride Corp

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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ACTIVE INGREDIENT:

Menthol, 1.0%

Topical Analgesic

Use

Pharmacy's Best Ice Gel to provide temporary relief of minor pains and aches in your body's joints and muscles associated with:

■ sports injuries ■ sprains ■ arthritis ■ burises

WARNINGS:

For external use only.

Do not apply to wound or damaged skin. Do not bandage the applied surface. Avoid contact with mucous membranes and eyes.

if condition worsens, discontinue use of this product and consult a physician if symptoms persist for more than 7 days.

Do not heat in microwave, add to hot water or any container where heating water may cause splattering and result in burns. Do not use with heating devices or pads.

KEEP OUT OF REACH OF CHILDREN.

In case of accidental ingestion, seek professional advice or contact a Posion Control Center immediately.

DIRECTIONS:

For Adults & Children 2 years & older.

Apply liberally to painful zone and massage until absorbed into the skin. Repeat 3 or 4 times daily. Do not apply to children below two years of age.

INACTIVE INGREDIENTS:

Water (Aqua), Camphor, Ethyl Alcohol, Sodium Hydroxide, Carbomer, Methylchoroisothiazolinone, Methylisothiazolinone, FD&C Blue No. 1.

label

PHARMACY BEST ICE
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58037-204
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
WATER (UNII: 059QF0KO0R)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER 934 (UNII: Z135WT9208)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 58037-204-01	227 g in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/01/2023

Labeler - New Pride Corp (884264198)

Revised: 4/2023

Document Id: f9c153f9-dfb6-5c7e-e053-6294a90a4417

Set id: f9c153f9-dfb5-5c7e-e053-6294a90a4417

Version: 1

Effective Time: 20230401