Aboniki Balm - Topical Pain Relief Balm by J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD

Drug Details [pdf]

ABONIKI BALM - TOPICAL PAIN RELIEF BALM- camphor, eucalyptus, menthol, methyl salicylate cream
J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD

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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Aboniki® Balm - Topical Pain Relief Balm

Drug Facts

Active Ingredients

Active Ingredients (In each gram)

Camphor 5.04%

Eucalyptus Oil 2.30%

Menthol 5.10%

Methyl Salicylate 4.25%

Purpose

Active Ingredients (In each gram)	Purpose
Camphor 5.04%	External Analgesic
Eucalyptus Oil 2.30%	External Analgesic
Menthol 5.10%	External Analgesic
Methyl Salicylate 4.25%	External Analgesic

USES

Temporarily relieves minor aches & pains related to:

arthritis
simple backaches
sore muscles
joint pain
dislocation
leg cramps
bruises
sprains
lumbago

Warning

For external use only.

Do not use

on wounds or damaged skin
with a heating pad
if you are allergic to any of the ingredients

Ask a doctor or pharmacist before use if you have

sensitive skin
redness over the affected area

When using this product

avoid contact with eyes and mucous membranes
do not bandage tightly

Stop use and ask a doctor if

rash, itching, or excessive irritation of the skin develops
condition worsens or symptoms persist for more than 7 days
symptoms 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.

Direction

Use only as directed
For adults and children over 12 years, apply to the affected area 3 to 4 times daily
Wash hands after use
For Children under 12 years, consult a doctor before use

Other Information

Store in a cool, dry place between 20 oC to 25 oC (68 oF - 77 oF)
Do not use if the seal is broken
See cap for lot no, mfg, and exp date

Inactive Ingredients

FD&C Yellow No.6, Lanolin, Paraffin, White Petrolatum.

Contact Info

Distributed by:

J. C. Udeozor & Sons Global Industries Limited

Email:

Info-US@aboniki.com

Mail:

300 Delaware Ave, Suite 210 #465
Wilmington, DE 19801

USA

Aboniki ® Balm - Topical Pain Relief Balm - Twin Pack [Two 25g (0.88 OZ) Jar Inside]

New Look
Same Powerful Formula
Fast and Deep Penetrating Pain Relief

Aboniki Balm 2 Pack

ABONIKI BALM - TOPICAL PAIN RELIEF BALM
camphor, eucalyptus, menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82729-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	23 mg in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	51 mg in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	42.5 mg in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	50.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
PARAFFIN (UNII: I9O0E3H2ZE)
LANOLIN (UNII: 7EV65EAW6H)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 82729-001-01	25 g in 1 JAR; Type 0: Not a Combination Product	06/01/2022
2	NDC: 82729-001-02	2 in 1 CARTON	06/01/2022
2	NDC: 82729-001-01	25 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/01/2022	07/04/2023

Labeler - J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD (851768299)

Revised: 7/2023

Document Id: ffadedbd-7446-bdca-e053-6394a90adc8c

Set id: de24a5a5-8780-ee4a-e053-2a95a90a961e

Version: 4

Effective Time: 20230704

J C