ACTIVE AGAIN- menthol lotion

ACTIVE AGAIN by

Drug Labeling and Warnings

ACTIVE AGAIN by is a Otc medication manufactured, distributed, or labeled by Hope Science Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

MENTHOL (1.25%)

PURPOSE

TOPICAL ANALGESIC

INDICATIONS:

For 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.
• Avoid contact with eyes.
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician.

Keep out of reach of children.

• If swallowed, get medical help or contact a poison control center right away.

DIRECTIONS:

Adults and children 2 yrs. of age and older, apply to affected area not more than 3 to 4 times a day. Children under 2 yrs. of age, consult a physician.

OTHER INFORMATION:

Store in a cool, dry place.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Caprylyl Glycol, Citric Acid, Esterified Fatty Acids (EFAC Proprietary Blend), Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Lecithin, Mentha Piperita (Peppermint) Oil, PEG-100
Stearate, Phenoxyethanol, Sodium Hydroxide, Tocopheryl Acetate, Water.

QUESTIONS?

1-866-628-8725
www.HopeScience.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACTIVE AGAIN 
menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71970-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ISOPROPYL BEHENATE (UNII: 1BWO0L9BHI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71970-303-45	120 mL in 1 JAR; Type 0: Not a Combination Product	08/30/2018
2	NDC: 71970-303-49	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/30/2018

Labeler - Hope Science Inc (049917199)