Lucky Ice Cold Analgesic by Delta Brands Inc IceColdAnglsicGelMnthol

Drug Details [pdf]

LUCKY ICE COLD ANALGESIC- menthol gel
Delta Brands 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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IceColdAnglsicGelMnthol

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

package label

LUCKY ICE COLD ANALGESIC
menthol gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/25/2022

Labeler - Delta Brands Inc (102672008)

Revised: 9/2023

Document Id: 04cad5ea-ec4e-d17a-e063-6294a90a68f5

Set id: ddce5f6e-599a-7148-e053-2a95a90a9a48

Version: 3

Effective Time: 20230907