GELIGA MUSCULAR- menthol, methyl salicylate cream 
Eagle Indo Pharma, PT

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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Geliga Muscular Cream

Active Ingredients

Purpose

External Analgeisc

Uses

For temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises, and sprains.

Warnings

For external use only.

Avoid contact with the eyes or mucous membrane.

When using this product

  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use otherwise than as directed.

Stop use and ask doctor if

  • Condition worsens.
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.
  • Pain persists for more than 10 days.

Pregnancy or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Directions

Other information

Store below 86 oF (30 oC).

Inactive Ingredients

Butylparaben, Carbomer, Ethylparaben, Fragrance, Glycerin, Methylparaben, Methyl glucose dioelate, Phenoxyethanol, Propylparaben, Trolamine, Water

Questions

Contact us at 1-800-645-0769

Package Label

30g NDC: 60954-004-30

30g Unit Box

Package Label

60g NDC: 60954-004-60

60g Unit Box

GELIGA  MUSCULAR
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TROLAMINE (UNII: 9O3K93S3TK)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60954-004-301 in 1 BOX05/08/2023
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:60954-004-601 in 1 BOX05/08/2023
260 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/08/2023
Labeler - Eagle Indo Pharma, PT (728682519)
Establishment
NameAddressID/FEIBusiness Operations
Eagle Indo Pharma, PT728682519manufacture(60954-004)

Revised: 9/2023
Document Id: 04c0b2b7-c7ab-12c2-e063-6394a90a3acf
Set id: fb2beb08-0ad6-a89d-e053-6294a90aa6fe
Version: 3
Effective Time: 20230907
 
Eagle Indo Pharma, PT