MUSCLE  - menthol gel 
WATER-JEL TECHNOLOGIES

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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Muscle Jel

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

Other information

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 Type HUMAN OTC DRUG Item Code (Source) NDC:59898-805
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59898-805-17 1728 in 1 CARTON
1 3.8 mL in 1 PACKET
2 NDC:59898-805-18 5 in 1 BOX, UNIT-DOSE
2 3.8 mL in 1 PACKET
3 NDC:59898-805-05 96 in 1 BOX, UNIT-DOSE
3 3.8 mL in 1 PACKET
4 NDC:59898-805-20 24 in 1 CARTON
4 3.8 mL in 1 PACKET
5 NDC:59898-805-24 3784 mL in 1 BOTTLE, PUMP
6 NDC:59898-805-21 473 mL in 1 BOTTLE, PUMP
7 NDC:59898-805-10 59 mL in 1 BOTTLE, SPRAY
8 NDC:59898-805-23 946 mL in 1 BOTTLE, PUMP
9 NDC:59898-805-22 80 mL in 1 BOTTLE, DISPENSING
10 NDC:59898-805-25 118 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 04/19/2010
Labeler - WATER-JEL TECHNOLOGIES (155522589)
Establishment
Name Address ID/FEI Business Operations
WATER-JEL TECHNOLOGIES 155522589 manufacture(59898-805)

Revised: 3/2013
Document Id: 973feabd-0342-4e95-b02c-909ce7265da1
Set id: 1af399af-07b0-4899-9bcc-1e244b63b1cf
Version: 3
Effective Time: 20130327
 
WATER-JEL TECHNOLOGIES