NATURAL 17 HERBAL SPLASH- menthol spray

NATURAL 17 HERBAL SPLASH by

Drug Labeling and Warnings

NATURAL 17 HERBAL SPLASH by is a Otc medication manufactured, distributed, or labeled by NATURAL 17, CHEMCO CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol …………………………………………...………………….……... 2%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

For temporary relief of minor pains on muscles and joints.

WARNINGS

For external use only.

Do not use on wounds or damaged skin, with a heating pad or on a child under 12 years of age.

Extremely flammable

Keep away from fire or flame.

WHEN USING

Use only as directed.
Avoid contact with eyes and mucous membranes.
If you experience an allergic reaction, discontinue use, and consult a physician.

Do not expose the area treated with product to heat or direct sunlight.

Stop use and ask a doctor if

Condition worsens.
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help, or contact a Poison Control Center right away.

Directions

Adults and Children over 12 years

Spray two to three pumps or as necessary to cover the affected area not more than three to four times daily.

Children under 12 years of age: do not use, consult a doctor.

Other information

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

INACTIVE INGREDIENT

Alcohol Denat, Water (Aqua), Eucalyptus Globulus Leaf Oil, Isopropyl Alcohol, Propylene Glycol, Fragrance (Parfum), Polysorbate 20, Mentha Arvensis Herb Oil, Thymus Vulgaris (Thyme) Oil, Aloe Barbadensis Leaf Extract, Glycerin, Benzyl Alcohol, Benzoic Acid, Sorbic Acid, Geraniol, Hexyl Cinnamal, Amyl Cinnamal, Citronellol, Hydroxycitronnellal, Linalool, Coumarin.

NATURAL 17 - HERBAL SPLASH

INGREDIENTS AND APPEARANCE

NATURAL 17 HERBAL SPLASH 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80770-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GERANIOL (UNII: L837108USY)
LINALOOL, (+)- (UNII: F4VNO44C09)
COUMARIN (UNII: A4VZ22K1WT)
EUCALYPTUS OIL (UNII: 2R04ONI662)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SORBIC ACID (UNII: X045WJ989B)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
THYME OIL (UNII: 2UK410MY6B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80770-020-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/15/2023

Labeler - NATURAL 17 (103497833)

Registrant - CHEMCO CORPORATION (032495954)

Establishment
Name	Address	ID/FEI	Business Operations
CHEMCO CORPORATION		032495954	manufacture(80770-020)