Simple Grace Hand Sanitizer: Package Insert and Label Information

SIMPLE GRACE HAND SANITIZER- alcohol gel
Advance Beauty Care 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(s)

Alcohol 70% v/v.

Purpose

Antiseptic

Use

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 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Aminomethyl Propanol, Butyrospermum Parkii, Carbopol, C13-14 Isoparaffin, Fragrance, Glycerin, Isopropyl Myristate, Polyacrylamide, Propylene Glycol, Laureth- 7 , Water

Package Label — Principal Display Panel

Distributed by Advance Beauty Care, Inc

Mission Viejo, California 92692

18 W.P.B.C, Wembley HA9 OAS England

Simple Grace Hand Sanitizer — Shea Butter (8oz gel) NDC: 79558-001-08

shea butter
(click image for full-size original)
SIMPLE GRACE HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79558-001
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
LAURETH-7
PROPYLENE GLYCOL
ISOPROPYL MYRISTATE
GLYCERIN
AMINOMETHYLPROPANOL
WATER
SHEA BUTTER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
POLYACRYLAMIDE (10000 MW)
C13-14 ISOPARAFFIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79558-001-08 236 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/13/2020
Labeler — Advance Beauty Care Inc (011603890)

Revised: 11/2020 Advance Beauty Care Inc

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