OTC Medication Information: Hand Cleanse – Strawberry Pomegranate

HAND CLEANSE — STRAWBERRY POMEGRANATE- triclosan gel
China Ningbo Shangge Cosmetic Technology Corp.

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.

Active Ingredient Purpose

Triclosan 0.15%…………………………….Antibacterial

Uses

forthe temporary relief of minor aches and pains of muscles and joints.

Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Other information

  • store at 20oC to 25oC (68o to 77oF)

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with

  • smoking
  • excessive phlegm
  • asthma
  • emphysema
  • persistent or chronic cough

When using this product do not

  • heat
  • microwafe
  • add to hot water or any container where healing water may cause splattering and result in burns
  • use in eyes or directly on mucous membranes
  • take by mouth or place in nostrils
  • apply to wounds or damaged skin
  • bandage skin

Consult a doctor and discontinue use if condition worsesn, persists for more than 1 week or tends to recur.

Directions

  • see important warnings under “When using this product”
  • adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: consult a physician.

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

label
(click image for full-size original)
label image

HAND CLEANSE — STRAWBERRY POMEGRANATE
triclosan gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-011
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (TRICLOSAN) TRICLOSAN 7.5 mg in 500 mg
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM C14-16 OLEFIN SULFONATE
SODIUM LAURETH SULFATE
COCO DIETHANOLAMIDE
SODIUM CHLORIDE
PEG-150 DISTEARATE
CITRIC ACID MONOHYDRATE
GLYCERIN
EDETATE DISODIUM
.ALPHA.-TOCOPHEROL ACETATE
METHYLCHLOROISOTHIAZOLINONE
D&C RED NO. 33
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58503-011-01 500 mg in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 05/24/2013
Labeler — China Ningbo Shangge Cosmetic Technology Corp. (529287434)
Establishment
Name Address ID/FEI Operations
China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture (58503-011)

Revised: 10/2019 China Ningbo Shangge Cosmetic Technology Corp.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Medication Sections

Medication Information by RSS

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.