SHINGBASE TOPICAL ANALGESIC- lidocaine, menthol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

JOONEM LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Temporary relieves minor pain

Authorization status:

OTC monograph not final

Summary of Product characteristics

SHINGBASE TOPICAL ANALGESIC- LIDOCAINE, MENTHOL CREAM
JOONEM LLC
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SHINGBASE TOPICAL ANALGESIC CREAM
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Lidocaine 4%
Menthol 1%
_PURPOSE_
Topical Analgesic
_INDICATIONS:_
Temporary relieves minor pain
_WARNINGS:_
Avoid contact with the eyes. If condition worsens, or if symptoms
persist for more than
7 days or clear up and occur again within a few days, discontinue use
of this product
and consult a physician
Do not apply to wounds or damaged skin.
Do not bandage tightly.
DO NOT USE
in large quantities, particularly over raw surfaces or blistered
areas.
KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL INGESTION!
If swallowed, get medical help or contact the poison control center
immediately.
_DIRECTIONS:_
use only as directed
adults and children 12 years of age and older: apply to affected area
not more than 3
to 4 times daily
children under 12 years of age: consult a doctor
_OTHER INFORMATION:_
Store at 20 to 25 C (68 to 77F)
_INACTIVE INGREDIENTS:_
L-arginine, Sodium Benzonate, Rectified Spirit, Disodium EDTA,
Phenoxyetanol,
Polysorbate 20, DM Water
PACKAGE LABELING:
SHINGBASE TOPICAL ANALGESIC
lidocaine, menthol cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:80327-002
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
LIDOCAINE
40 mg in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
10 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ARGININE (UNII: 94ZLA3W45F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
JOONEM LLC
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:80327-002-
01
120 g in 1 BOTTLE; Type 0: Not a Combination
Product
09/01/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
D