OTC Medication Information: Witch Hazel

WITCH HAZEL- witch hazel solution
Supervalu, 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

Witch hazel 86%

Purpose

Astringent

Uses

for relief of minor skin irritations due to:

  • insect bites
  • minor cuts
  • minor scrapes

Warnings

For external use only

When using this product

•avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

apply as often as needed

Inactive ingredient

alcohol 14% by volume

  • cleans and refreshes skin
  • tones skin
  • soothes sunburn

Distriubuted by SUPERVALE INC.

Eden Praiie, MN 55344

Contact us at 1-877-932-7948

or www.supervalu-ourownbrands.com

principal display panel

NDC 41163-822-43

EQUALINE

witch hazel

astringent

hamamelis water

for relief of minor skin irritations due to:

  • insects bites
  • minor cuts
  • minor scrapes

16 FL OZ (1 PT ) 473 mL

image description
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WITCH HAZEL
witch hazel solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-822
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL 979 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41163-822-43 473 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 05/29/2009
Labeler — Supervalu, Inc (006961411)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (41163-822)

Revised: 07/2021 Supervalu, 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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