Drug Labeling and Warnings

Drug Details [pdf]

GOLD ICE- menthol cream 
Eden's Answers Inc.

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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Menthol 6.25%

Menthol 6.25%...............................External Analgesic

Temporary relief of minor aches and pains of muscles and joint associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

For external use only

Flammable: Keep away from fire or flame

When using this product

• do not apply to wounds or damaged skin
• do not bandange tightly
• do not use with a heating pad
• avoid contact with the eyes or mucous membranes
• use only as directed

Stop Use and ask a Doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness or skin irritation occurs

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

• Adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
• Children under 12 years of age: consult a physician

• close container tightly and store at room temperature
• do not use if plastic seal around cap is broken or missing
• store in a cool, dry place

Beeswax, Capscium Frutescens Fruit Powder, Lavandula Angustifolia (Lavender) Flower Extract, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Leaf, Rosmarinus Officinalis (Rosemary) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Verbascum Thapsus Extract

Questions or Comments?

Sprigs Life Inc PO Box 147

Wilmot, Ohio 44689 1-888-9907763

Mon-Fri 8am-3pm EST

GOLD ICE

PAIN RELIEF CREAM

MENTHOL 6.25%

• ​Fast acting
• Temporary pain relief
• Non-greasy

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

Net Wt. 2.5 ox (71 g)

Lot: Manf:

Exp

GOLD ICE 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72226-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
ROSEMARY (UNII: IJ67X351P9)
ROSEMARY OIL (UNII: 8LGU7VM393)
VERBASCUM THAPSUS (UNII: C9TD27U172)
YELLOW WAX (UNII: 2ZA36H0S2V)
TABASCO PEPPER (UNII: J1M3NA843L)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72226-001-71	71 g in 1 JAR; Type 0: Not a Combination Product	04/16/2018	08/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/16/2018	08/14/2019

Labeler - Eden's Answers Inc. (030063091)

Establishment
Name	Address	ID/FEI	Business Operations
Eden's Answers, Inc.		030063091	manufacture(72226-001)

Revised: 8/2019

Document Id: 91d28bb3-cde4-5cdd-e053-2995a90a5438

34390-5

Set id: 6972b912-49ed-052f-e053-2a91aa0aa6dd

Version: 4

Effective Time: 20190814

 

Eden's Answers Inc.