80465-015-04

CAMPHOR- camphor cream
EROS GLOBAL CORP

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.

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80465-015-04

Apply to affected areas not more than 1-3 times daily.

For external use only.
Avoid contact with eyes.
If you are breastfeeding, consult a health care practitioner prior to use.

Aqua, Caprylic/Capric Triglyceride, Paraffinum Liquidum, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Petrolatum, Cetyl Alcohol, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine, Thymus Vulgaris (Thyme) Oil, Stearyl Alcohol, Parfum, Carbomer, Canola Oil, Rosmarinus Officinalis (Rosemary) Oil, Citral, D-Limonene, Geraniol, Linalool.

Helps relieve respiratory discomfort, cough, and congestion.

Keep out of reach of the children.

External Analgesic

Camphor……………………………………..………………….……... 0.15%

cream 4oz

CAMPHOR
camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80465-015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)
CITRAL (UNII: T7EU0O9VPP)
LINALOOL, (+)- (UNII: F4VNO44C09)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CARBOMER 940 (UNII: 4Q93RCW27E)
CANOLA OIL (UNII: 331KBJ17RK)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
GERANIOL (UNII: L837108USY)
WATER (UNII: 059QF0KO0R)
DIMETHICONE 1000 (UNII: MCU2324216)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80465-015-04	113 g in 1 BOTTLE; Type 0: Not a Combination Product	09/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/29/2020

Labeler - EROS GLOBAL CORP (117597821)

Registrant - CHEMCO CORPORATION (032495954)

Name	Address	ID/FEI	Business Operations
Establishment
CHEMCO CORPORATION		032495954	manufacture(80465-015)