THERACARE ICE BLUE GEL PAIN RELIEVING- menthol gel

Theracare Ice Blue Gel by

Drug Labeling and Warnings

Theracare Ice Blue Gel by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, ANICARE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 2%

Purpose

Topical analgesic

Uses

● temporarily relieves minor aches and pains of muscles and joints associated with:

● simple backache

● arthritis

● strains

● bruises

● sprains

Warnings

For external use only

When Using this product

• with other topical pain relievers
• with heating pads or heating devices
• avoid contact with eyes
• do not bandage tightly
• do not apply to wounds or damage skin

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

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 (800-222-1222) 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 to 4 times daily
• children under 2 years of age: ask a doctor before using this product

Other information

• do not freeze
• store at room temperature
• keep container tightly closed when not in use
• do not use, pour, spill, or store near heat or open flame

Inactive ingredients

ammonium hydroxide, benzyl alcohol, carbopor 940, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, PEG-40 hydrogenated castor oil, sodium hydroxide, thymol, water

Questions or comments?

Customer care 866-326-1313

Principal Display

INGREDIENTS AND APPEARANCE

THERACARE ICE BLUE GEL  PAIN RELIEVING
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-217
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
BENZYL ALCOHOL (UNII: LKG8494WBH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
AMMONIA (UNII: 5138Q19F1X)
CARBOMER 940 (UNII: 4Q93RCW27E)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
THYMOL (UNII: 3J50XA376E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-217-01	226.8 g in 1 JAR; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2022

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED		916837425	manufacture(71101-217)