PHQUIROGEL- camphor, menthol gel

PHQUIROGEL by

Drug Labeling and Warnings

PHQUIROGEL by is a Otc medication manufactured, distributed, or labeled by Issislen Laboratori S.L.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Camphor (3.01%)

Menthol (2.10%)

Purpose

Pain Relieving

Uses

• For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains bruises and sprains.

Warnings

For external use only

Do not use

• on wounds or damaged skin
• with a bandage to cover the surface

When using this product

• avoid contact with the eyes

Stop use and ask a doctor if

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 6 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• Children under 6 years of age: Consult a doctor.

Inactive Ingredients

ALCOHOL DENAT., BENZYL ALCOHOL, CARBOMER, DISODIUM EDTA, FD&C BLUE NO.1, FD&C YELLOW NO.5, GLYCERIN, GINSENG, PEG-7 GLYCERYL COCOATE, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM BENZOATE, SODIUM CHLORIDE, TOCOPHEROL, TRIETHANOLAMINE,
WATER.

Package Insert:

Package Labeling:

INGREDIENTS AND APPEARANCE

PHQUIROGEL 
camphor, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70544-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	30.1 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	21 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
ASIAN GINSENG (UNII: CUQ3A77YXI)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70544-001-01	1 in 1 BOX	04/05/2016
1		75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/04/2016

Labeler - Issislen Laboratori S.L. (463538806)