NATUREANCE BODY BALM- camphor liquid

NATUREANCE BODY BALM by

Drug Labeling and Warnings

NATUREANCE BODY BALM by is a Otc medication manufactured, distributed, or labeled by EROS GLOBAL CORP, CHEMCO CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor 1%

PURPOSE

External Analgesic

USE

For the temporary relief of pain.

WARNINGS

For external use only. · Ask a doctor before use if you have redness over affected area.

WHEN USING

Avoid contact with eyes.
Use only as directed.
Do not apply to wounds or damaged, broken, or irritated skin.
Do not bandage tightly or use with a heating pad

If you experience an allergic reaction, discontinue use, and consult a physician.

STOP USE

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

If pregnant 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

Apply to affected area not more than three to four times daily.

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

OTHER SAFETY 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), Glycerin, Polysorbate 20, Fragrance, Parfum, Arnica Montana Flower Extract, Cymbopogon Nardus (Citronella) Oil, FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090), Benzyl Benzoate, Limonene, Benzyl Salicylate, Geraniol, Hexyl Cinnamal, Citral, Amyl Cinnamal, Citronellol, Linalool, Hydroxycitronellal, Eugenol, Farnesol.

NATUREANCE BODY BALM

INGREDIENTS AND APPEARANCE

NATUREANCE BODY BALM 
camphor liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80465-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
FARNESOL (UNII: EB41QIU6JL)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CITRONELLA OIL (UNII: QYO8Q067D0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
BENZYL BENZOATE (UNII: N863NB338G)
GERANIOL (UNII: L837108USY)
CITRAL (UNII: T7EU0O9VPP)
EUGENOL (UNII: 3T8H1794QW)

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80465-100-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/03/2023

Labeler - EROS GLOBAL CORP (117597821)

Registrant - CHEMCO CORPORATION (032495954)

Establishment
Name	Address	ID/FEI	Business Operations
CHEMCO CORPORATION		032495954	manufacture(80465-100)