Your browser does not support JavaScript! MUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]
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RxNorm Names

MUSCLE (menthol) gel
[WATER-JEL TECHNOLOGIES]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient

Menthol 3.5%

Purpose

External analgesic

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

When using this product

  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

  • conditions worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

Keep out of the reach of children

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

Directions

  • 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: consult a doctor

Other information

  • store at room temperature
  • apply product directly onto sore areas of the body
  • massage well for best results
  • following application, wash hands well and rinse with cool water

Inactive ingredients

aloe barbadensis leaf juice, angelica archangelica root extract, camphor, carbomer, DMDM hydantoin, isopropyl alcohol, methylparaben, panax ginseng root extract, purified water, triethanolamine

Questions?

1-800-275-343

info@waterjel.com   www.waterjel.com

Principal Display Panel

Image of PDP
MUSCLE  
menthol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59898-805
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
ANGELICA ARCHANGELICA ROOT 
ASIAN GINSENG 
ALOE VERA LEAF 
CARBOMER HOMOPOLYMER TYPE C 
TROLAMINE 
DMDM HYDANTOIN 
METHYLPARABEN 
CAMPHOR (NATURAL) 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-805-171728 in 1 CARTON
13.8 mL in 1 PACKET
2NDC:59898-805-185 in 1 BOX, UNIT-DOSE
23.8 mL in 1 PACKET
3NDC:59898-805-0596 in 1 BOX, UNIT-DOSE
33.8 mL in 1 PACKET
4NDC:59898-805-2024 in 1 CARTON
43.8 mL in 1 PACKET
5NDC:59898-805-243784 mL in 1 BOTTLE, PUMP
6NDC:59898-805-21473 mL in 1 BOTTLE, PUMP
7NDC:59898-805-1059 mL in 1 BOTTLE, SPRAY
8NDC:59898-805-23946 mL in 1 BOTTLE, PUMP
9NDC:59898-805-2280 mL in 1 BOTTLE, DISPENSING
10NDC:59898-805-25118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/19/2010
Labeler - WATER-JEL TECHNOLOGIES (155522589)
Establishment
NameAddressID/FEIBusiness Operations
WATER-JEL TECHNOLOGIES155522589manufacture(59898-805)

Revised: 3/2013
 
WATER-JEL TECHNOLOGIES

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