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, triethanolamine, water

Questions?

1-800-275-343 info@waterjel.com www.waterjel.com

Manufactured by Water-Jel Technologies Inc.

50 Broad Street, Carlstadtn NJ 07072 USA

Principal Display Panel

MJ16

MUSCLE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-805
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-805-171728 in 1 CARTON04/19/2010
13.8 mL in 1 PACKET; Type 0: Not a Combination Product
2NDC:59898-805-185 in 1 BOX, UNIT-DOSE04/19/2010
23.8 mL in 1 PACKET; Type 0: Not a Combination Product
3NDC:59898-805-0596 in 1 BOX, UNIT-DOSE04/19/2010
33.8 mL in 1 PACKET; Type 0: Not a Combination Product
4NDC:59898-805-2024 in 1 CARTON04/19/2010
43.8 mL in 1 PACKET; Type 0: Not a Combination Product
5NDC:59898-805-243784 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/19/2010
6NDC:59898-805-21473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/19/2010
7NDC:59898-805-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/17/2013
8NDC:59898-805-23946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/19/2010
9NDC:59898-805-2280 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/19/2010
10NDC:59898-805-25118 mL in 1 TUBE; Type 0: Not a Combination Product04/19/2010
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: 12/2020
Document Id: b70fb82c-4c5d-e4c7-e053-2995a90aa022
Set id: 1af399af-07b0-4899-9bcc-1e244b63b1cf
Version: 5
Effective Time: 20201222
 
WATER-JEL TECHNOLOGIES