LUCKY ICE COLD ANALGESIC- menthol gel

Lucky Ice Cold Analgesic by

Drug Labeling and Warnings

Lucky Ice Cold Analgesic by is a Otc medication manufactured, distributed, or labeled by Delta Brands Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 1.25%

Purpose

Topical Analgesic

Uses

temporary relieves minor aches and pains of muscles and joints associated with:

■ arthritis ■ simple backache ■ strains ■ bruises ■ sports 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 eyes ■ do not apply to wounds or damaged skin ■ do not bandage tightly

Stop use and ask a doctor if

■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days ■ redness or irritation develops

Keep out of reach of children

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 product. ■ adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily ■ children under 2 years of age: ask a doctor

Other information

■ store at controlled room temperature 20 to 25ºC (68 to 77ºF) in a tightly closed container ■ do not use, pour, spill or store near heat or open flame

Inactive Ingredients

benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no.1, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, sodium hydroxide, water

Package Label

INGREDIENTS AND APPEARANCE

LUCKY ICE COLD ANALGESIC 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-211-07	198 g in 1 JAR; Type 0: Not a Combination Product	04/25/2022
2	NDC: 20276-211-08	227 g in 1 JAR; Type 0: Not a Combination Product	04/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/25/2022

Labeler - Delta Brands Inc (102672008)