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NDC 71423-0825-01 Instant Therapy 31; 13 mg/mL; mg/mL Details

Instant Therapy 31; 13 mg/mL; mg/mL

Instant Therapy is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Hampshire Laboratories Inc. The primary component is CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	71423-0825
Product ID	71423-825_4f2ed5d4-d9d5-405d-e054-00144ff8d46c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Instant Therapy
Proprietary Name Suffix	n/a
Non-Proprietary Name	CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	31; 13
Active Ingredient Units	mg/mL; mg/mL
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM
Labeler Name	Hampshire Laboratories Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 71423-0825-01 (71423082501)

Pricing Information	N/A
NDC Package Code	71423-825-01
Billing NDC	71423082501
Package	75 mL in 1 TUBE (71423-825-01)
Marketing Start Date	2017-05-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cc9719ec-7e22-48bc-85cc-6835b6c31860 Details

Drug Facts

Active ingredients

Camphor 3.1%

Menthol 1.3%

Purpose

Topical Analgesic

Indications

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

Warnings

• For external use only.

• Avoid contact with eyes.

• If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

• If swallowed, consult physician.

Do not apply to

• wounds or damaged skin.

• Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions

• Adults and children two years of age or older: Apply to affected area not more than three to four times daily.

• Children under two years of age: consult a physician.

Additional Information

Store at room temperature.

Inactive ingredients

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), BHT, Cetyl Alcohol, Cinnamomum Cassia (Cassia) Leaf Oil, Copper Sulfate, Diazolidinyl Urea, Eucalyptus Globulus Oil, Glyceryl Stearate, Methyl Paraben, PEG-100 Stearate, Polysorbate-20, Propyl Paraben, Propylene Glycol, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethanolamine, FD&C Blue #1.

Package Labeling:

INGREDIENTS AND APPEARANCE

INSTANT THERAPY

camphor (synthetic), menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71423-825
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	31 mg in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	13 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71423-825-01	75 mL in 1 TUBE; Type 0: Not a Combination Product	05/09/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/09/2017

Labeler - Hampshire Laboratories Inc (160736109)

Revised: 5/2017

Document Id: 4f2ed5d4-d9d5-405d-e054-00144ff8d46c

Set id: cc9719ec-7e22-48bc-85cc-6835b6c31860

Version: 2

Effective Time: 20170510