OTC Medication Information: SolGreat

SOLGREAT- alcohol gel
PANATURAL USA, 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.

Active Ingredient

Alcohol 70% v/v.

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Flammable. Keep away from heat or flame.

´╗┐Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-300 C (59-860 F)
  • Avoid freezing and excessive heat above 400 C (1040 F)

Inactive ingredients

aminomethyl propanol, carbomer, glycerin, hydrogen peroxide, purified water USP, tocopheryl acetate.

Package Label — Principal Display Panel

60 mL

60 mL
(click image for full-size original)

237 mL

237 mL
(click image for full-size original)

500 mL

500 mL
(click image for full-size original)

1000 mL

1000 mL
(click image for full-size original)

3785 mL

3785 mL
(click image for full-size original)

1000000 mL

1000000 mL
(click image for full-size original)
SOLGREAT
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73913-008
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
AMINOMETHYLPROPANOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
GLYCERIN
HYDROGEN PEROXIDE
.ALPHA.-TOCOPHEROL ACETATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73913-008-01 60 mL in 1 BOTTLE, PLASTIC None
2 NDC:73913-008-02 237 mL in 1 BOTTLE, PLASTIC None
3 NDC:73913-008-03 500 mL in 1 BOTTLE, PLASTIC None
4 NDC:73913-008-04 1000 mL in 1 BOTTLE, PLASTIC None
5 NDC:73913-008-05 3785 mL in 1 BOTTLE, PLASTIC None
6 NDC:73913-008-06 1000000 mL in 1 TANK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/08/2020
Labeler — PANATURAL USA, INC. (029572239)

Revised: 06/2020 PANATURAL USA, INC.

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.

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.

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