PRIYAL ICE GEL- menthol, camphor cream

Priyal Ice Gel by

Drug Labeling and Warnings

Priyal Ice Gel by is a Otc medication manufactured, distributed, or labeled by Priyal Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor..............0.5 %

Menthol...............1.25 %

PURPOSE

Menthol 1.25 %................Topical Analgesic

Camphor 0.5 %...............Topical Analgesic

DOSAGE & ADMINISTRATION

• 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

INDICATIONS & USAGE

Uses:

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

• arthritis
• simple backache
• strains
• bruises
• sport injuries
• sprains

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

WARNINGS

For external use only.

Do not use

• with other topical pain relivers
• 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 iritation develops

It pregnant or breast-feeding, ask a health professional before use.

INACTIVE INGREDIENT

Aqua, Propylene Glycol, Carbomer, Methyl Salicylate, Sodium Hydroxide, Sodium Methyl Paraben, Sodium Propylene Paraben, FD&C Blue #1 Cl 42090

OTHER SAFETY INFORMATION

Other information

• Store at room temperature 59-86 F (15-30 C)
• Keep jar tightly closed and away from open heat or flame

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRIYAL ICE GEL 
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72822-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72822-016-02	227 g in 1 JAR; Type 0: Not a Combination Product	01/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/26/2018

Labeler - Priyal Cosmetics (675482356)