HANDYMAN FREEZE PAIN RELIEF- menthol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Handyman Stuff, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.
Authorization status:
OTC monograph not final
Authorization number:
73103-119-88

HANDYMAN FREEZE PAIN RELIEF- menthol gel

Handyman Stuff, LLC

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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Handyman Freeze Pain Relief Gel

DRUG FACTS:

Active Ingredient:

Menthol 4.00%

Topical Analgesic

Indications :

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis,

simple backache, sprains, bruises and strains.

Warnings :

For external use only.

Avoid contact with eyes.

If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

Do not apply

to wounds or damaged skin.

Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions :

Adults and children two-years of age or older: Apply to affected area not more than three to four

times daily.

Children under two-years of age: consult a physcian.

Additional Information:

Store at room temperature.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arcticum Lappa (Burdock)

Root Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract,

Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glucosamine Sulfate, Ilex

Paraguariensis (Yerba Mate) Extract, Isopropyl Myristate, Magnesium Sulfate, Methylsulfonylmethane

(MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E),

Triethanolamine, FD&C Blue #1, FD&C Yellow #5.

Package Labeling:

HANDYMAN FREEZE PAIN RELIEF

menthol gel

Handyman Stuff, LLC

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7310 3-119

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

40 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

WATER (UNII: 0 59 QF0 KO0 R)

ARCTIUM LAPPA RO O T (UNII: 59 7E9 BI3Z3)

ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)

INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

GLUCO SAMINE SULFATE (UNII: 1FW7WLR731)

ILEX PARAGUARIENSIS LEAF (UNII: 1Q9 53B4O4F)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

MAGNESIUM SULFATE, UNSPECIFIED FO RM (UNII: DE0 8 0 37SAB)

DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

TRO LAMINE (UNII: 9 O3K9 3S3TK)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7310 3-119 -8 8

8 8 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 5/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 5/0 1/20 19

Labeler -

Handyman Stuff, LLC (116797224)

Revised: 5/2019

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