MUSCLE by WATER-JEL TECHNOLOGIES MUSCLE- menthol gel

MUSCLE by

Drug Labeling and Warnings

MUSCLE by is a Otc medication manufactured, distributed, or labeled by WATER-JEL TECHNOLOGIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MUSCLE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59898-805
Route of Administration	TOPICAL

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	04/19/2010
1		3.8 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 59898-805-18	5 in 1 BOX, UNIT-DOSE	04/19/2010
2		3.8 mL in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 59898-805-05	96 in 1 BOX, UNIT-DOSE	04/19/2010
3		3.8 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 59898-805-20	24 in 1 CARTON	04/19/2010
4		3.8 mL in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 59898-805-24	3784 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/19/2010
6	NDC: 59898-805-21	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/19/2010
7	NDC: 59898-805-10	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/17/2013
8	NDC: 59898-805-23	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/19/2010
9	NDC: 59898-805-22	80 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/19/2010
10	NDC: 59898-805-25	118 mL in 1 TUBE; Type 0: Not a Combination Product	04/19/2010

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)