EXTERNAL ANALGESIC CREAM WITH MENTHOL 5%- menthol 5% cream

External Analgesic Cream with Menthol 5% by

Drug Labeling and Warnings

External Analgesic Cream with Menthol 5% by is a Otc medication manufactured, distributed, or labeled by BLOOMWELL GARDENS LLC, Jiangxi Hemei Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Menthol 5%

INACTIVE INGREDIENT

Water, Propylene Glycol, Carbomer Homopolymer, Glycerin,

Edetate Disodium, Hydroxyacetophenone, 1,2-Hexanediol,

Mentha Arvensis Leaf, Chrysanthemum Indicum Top,

Portulaca, Polyoxyl 40 Hydrogenated Castor Oil

INDICATIONS & USAGE

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

WARNINGS

For external use only

WHEN USING

avoid contact with eyes,

mucous membranes do not bandage tightly

STOP USE

Stop use and ask a doctor if: condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use

DOSAGE & ADMINISTRATION

- Adults and children 12 years and older:

Clean the affected area with mild soap and warm water, then pat dry.

Apply a thin, even layer to the affected area not more than 3 to 4 times

daily.

- Children under 12 years: consult a doctor

PURPOSE

Temporary relief of minor aches and pains

DO NOT USE

on wounds or damaged skin with a heating pad

if allergic to menthol or any ingredient in this product

OTHER SAFETY INFORMATION

Store at 15–30°C (59–86°F)

Protect from excessive moisture and direct sunlight

Keep the carton for full labeling

Flammable: keep away from fire or flame

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTERNAL ANALGESIC CREAM WITH MENTHOL 5% 
menthol 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85284-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
WATER (UNII: 059QF0KO0R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PORTULACA GRANDIFLORA LEAF (UNII: VHJ480553K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHRYSANTHEMUM INDICUM TOP (UNII: 607YAE70V1)
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85284-010-01	50 g in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/02/2025

Labeler - BLOOMWELL GARDENS LLC (124839891)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd.		724892056	manufacture(85284-010)