BLUE STAR- camphor ointment
GHC Group, LLC

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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Blue Star Ointment - Drug Facts Label

Active ingredient

Camphor 1.24%

Purpose

Topical Analgesic Anti-itch

Use

for temporary relief of pain and itching associated with minor skin irritations.

Warnings

For external use only

When using this product avoid contact with eyes

Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

Keep out of reach of children

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

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.
CHildren under 2 years of age: Consult a doctor

Other Information:

Store between 15°-30°C (59°-86°F)

Inactive Ingredients:

Benzoic Acid, lanolin oil, methyl salicylate, mineral oil, paraffin wax, petrolatum, salicylic acid, aloe oil extract

www.bluestarointment.com

Dist. By G.H.C. Group, L.L.C.

New Orleans, LA 70129

1-888-844-4043

Image of Label

BlueStarOintment2ozLabel.jpg Label

BLUE STAR
camphor ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68429-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	12.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
LANOLIN OIL (UNII: OVV5IIJ58F)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
SALICYLIC ACID (UNII: O414PZ4LPZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68429-201-02	56 g in 1 CONTAINER; Type 0: Not a Combination Product	11/08/2017	11/08/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/30/2012	11/08/2017

Labeler - GHC Group, LLC (112629444)

Name	Address	ID/FEI	Business Operations
Establishment
Dr. G. H. Tichenor's Antiseptic Company		008161556	manufacture(68429-201)

Revised: 11/2017

Document Id: 5d7de6be-b7b6-15e3-e053-2a91aa0aadad

Set id: ec3ac549-5dbf-4229-ad3a-eeddad6d0e5a

Version: 3

Effective Time: 20171108

GHC Group, LLC