Drug Facts

AQUACOOL MULTI ROLL- menthol gel
Pharmanuco

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.

----------

Drug Facts

MENTHOL

Camphor, Carbomer, Eucalyptus Globulus Leaf Oil, Witch Hazel Extract, Arnica Montana Flower Extract, Aloe Barbadensis Leaf Extract, Acetyl Glucosamine, etc.

External Analgesic: Multi Action Recovery for Warm Up & Cool Down

keep out of reach of the children

1. Apply gel on to affected areas.

2. Massage until completely absorbed into skin.

3. Repeat as many as needed.

* It is recommended to control the amount and times of use depending on your symptom.

for external use only

Avoid contact with eyes. Stop if irritation occurs. Avoid bandaging tightly. Keep out of reach of children. Ask your doctor before use if pregnant or breast feeding

AQUACOOL MULTI ROLL
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70759-0010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
CAMPHOR, (-)- (UNII: 213N3S8275)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
WITCH HAZEL (UNII: 101I4J0U34)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70759-0010-1	100 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	12/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/01/2017

Labeler - Pharmanuco (687825097)

Registrant - Pharmanuco (687825097)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmanuco		687825097	manufacture(70759-0010)