Label: CAMPHOR gel
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Contains inactivated NDC Code(s)
NDC Code(s): 49283-331-04, 49283-331-05, 49283-331-28 - Packager: Chemco Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated June 23, 2020
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- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAMPHOR
camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49283-331 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 94.8 mL in 99 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) WATER (UNII: 059QF0KO0R) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) POLYSORBATE 20 (UNII: 7T1F30V5YH) OLETH-20 (UNII: YTH167I2AG) MENTHOL (UNII: L7T10EIP3A) CARBOMER 940 (UNII: 4Q93RCW27E) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) DIPROPYLENE GLYCOL MONOCAPRATE MONOCAPRYLATE (UNII: 5980W979EL) METHYLPARABEN (UNII: A2I8C7HI9T) DMDM HYDANTOIN (UNII: BYR0546TOW) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49283-331-28 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/11/2020 2 NDC:49283-331-05 18927 mL in 1 PAIL; Type 0: Not a Combination Product 06/23/2020 3 NDC:49283-331-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/11/2020 Labeler - Chemco Corporation (032495954) Registrant - Chemco Corporation (032495954) Establishment Name Address ID/FEI Business Operations Chemco Corporation 032495954 manufacture(49283-331)