FIRST AID BEAUTY FAB ULTRA REPAIR INTENSE HYDRATION SKIN PROTECTANT VANILLA CINNAMON- colloidal oatmeal cream

First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon by

Drug Labeling and Warnings

First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Colloidal Oatmeal 0.5%

Purpose

Skin Protectant

Uses

• Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

Warnings

For external use only.

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

Do not get into eyes.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

Directions

Apply as needed

INACTIVE INGREDIENT

Water, stearic acid, glycerin, C12-15 alkyl benzoate, caprylic /capric, triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalane, phenoxyethanol, caprylyl glycol, xanthan gum, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, cocos nucifera (coconut) fruit extract, ricinus communis (castor) seed oil, vanillin, ethyl butyrate, ethyl hydroxypyrone, acetoin, phenethyl acetate, methyl 2-phenylacetate,dimethylhydroxy furanone, methylcyclopentenolone, delta decalactone

Questions:

888-FAB-3063

SPL UNCLASSIFIED SECTION

MADE IN USA

FIRST AID BEAUTY LTD

NEWTON, MA 02458

WWW.FIRSTAIDBEAUTY.COM

PRINCIPAL DISPLAY PANEL - 396.8 g (14 oz)

First Aid Beauty

FAB

Ultra Repair® Cream

Intense Hydration

Skin Protectant Colloidal Oatmeal

VANILLA CINNAMON

Net Wt. 396.8 g (14 oz)

INGREDIENTS AND APPEARANCE

FIRST AID BEAUTY FAB ULTRA REPAIR INTENSE HYDRATION SKIN PROTECTANT VANILLA CINNAMON 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
VANILLIN (UNII: CHI530446X)
ETHYL BUTYRATE (UNII: UFD2LZ005D)
ETHYL HYDROXYPYRONE (UNII: L6Q8K29L05)
SQUALANE (UNII: GW89575KF9)
ACETOIN (UNII: BG4D34CO2H)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
PHENETHYL ACETATE (UNII: 67733846OW)
DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYLCYCLOPENTENOLONE (UNII: 627E92X64B)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
TETRASODIUM EDTA (UNII: MP1J8420LU)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
CERAMIDE NP (UNII: 4370DF050B)
TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)
COCOS NUCIFERA (COCONUT) FRUIT (UNII: 3RT3536DHY)
DELTA-DECALACTONE (UNII: CNA0S5T234)
METHYL PHENYLACETATE (UNII: D4PDC41X96)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-048-39	396.8 g in 1 JAR; Type 0: Not a Combination Product	10/01/2024
2	NDC: 84126-048-01	2 in 1 PACKAGE	10/01/2024
2		396.8 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/01/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)