GOLD BOND ORIGINAL STRENGTH- dimethicone and menthol lotion
GOLD BOND EXTRA STRENGTH- dimethicone and menthol lotion
Chattem, 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.

----------

Gold Bond Body Lotion

Drug Facts - Original Strength Gold Bond Body Lotion

Active ingredients

Dimethicone 5%

Purpose

Skin protectant

Active ingredients

Menthol 0.15%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with

minor skin irritation
minor burns
rashes due to poison ivy, oak or sumac
insect bites
sunburn
temporarily protects and helps relieve chapped or cracked skin

Warnings

For external use only

Do not use on

deep or puncture wounds
animal bites
serious burns

When using this product

avoid contact with eyes

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
if redness, irritation, swelling or pain persists or increases

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

adults and children 2 years and older: apply freely to affected area 3 or 4 times daily

children under 2 years: consult a doctor

Inactive ingredients

water, glycerin, stearamidopropyl PG-dimonium chloride phosphate, petrolatum, emulsifying wax, aloe barbadensis leaf juice, cetyl alcohol, stearyl alcohol, distearyldimonium chloride, propylene glycol, steareth-21, steareth-2, tocopheryl acetate, disodium EDTA, imidazolidinyl urea, propylparaben, methylparaben, triethanolamine, fragrance (227-156)

Drug Facts – Extra Strength Gold Bond Body Lotion

Active ingredients

Dimethicone 5%

Purpose

Skin protectant

Active ingredients

Menthol 0.5%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with

minor skin irritation
minor burns
rashes due to poison ivy, oak or sumac
insect bites
sunburn
temporarily protects and helps relieve chapped or cracked skin

Warnings

For external use only

Do not use on

deep or puncture wounds
animal bites
serious burns

When using this product

avoid contact with eyes

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
if redness, irritation, swelling or pain persists or increases

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

adults and children 2 years and older: apply freely to affected area 3 or 4 times daily

children under 2 years: consult a doctor

Inactive ingredients

PRINCIPAL DISPLAY PANEL

ORIGINAL STRENGTH GOLD BOND® BODY LOTION
MEDICATED HEALING SINCE 1908®
TRIPLE ACTION RELIEF FOR DRY & ITCHY SKIN
14 oz (396 g)

PRINCIPAL DISPLAY PANEL
ORIGINAL STRENGTH GOLD BOND BODY LOTION
TRIPLE ACTION RELIEF FOR DRY & ITCHY SKIN
14 oz (396 g)

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH GOLD BOND® BODY LOTION
MEDICATED HEALING SINCE 1908®
TRIPLE ACTION RELIEF FOR EXTRA DRY & ITCHY SKIN
14 oz (396 g)

PRINCIPAL DISPLAY PANEL
EXTRA STRENGTH GOLD BOND BODY LOTION
TRIPLE ACTION RELIEF FOR EXTRA DRY & ITCHY SKIN
14 oz (396 g)

GOLD BOND ORIGINAL STRENGTH
dimethicone and menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0610
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.05 g in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.0015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARETH-2 (UNII: V56DFE46J5)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARETH-21 (UNII: 53J3F32P58)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
EDETATE DISODIUM (UNII: 7FLD91C86K)
IMIDUREA (UNII: M629807ATL)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-0610-2	396 g in 1 BOTTLE; Type 0: Not a Combination Product	02/03/1998	06/24/2018
2	NDC:41167-0610-8	226 g in 1 BOTTLE; Type 0: Not a Combination Product	02/03/1998	05/11/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	02/03/1998	06/24/2018

GOLD BOND EXTRA STRENGTH
dimethicone and menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0640
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.05 g in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.005 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
EDETATE DISODIUM (UNII: 7FLD91C86K)
IMIDUREA (UNII: M629807ATL)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-0640-2	396 g in 1 BOTTLE; Type 0: Not a Combination Product	02/03/1998	08/10/2018
2	NDC:41167-0640-8	226 g in 1 BOTTLE; Type 0: Not a Combination Product	02/03/1998	09/15/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	02/03/1998	08/10/2018

Labeler - Chattem, Inc. (003336013)

Name	Address	ID/FEI	Business Operations
Establishment
Chattem Plant 2		830410721	ANALYSIS(41167-0610, 41167-0640) , LABEL(41167-0610, 41167-0640) , MANUFACTURE(41167-0610, 41167-0640) , PACK(41167-0610, 41167-0640)

Revised: 5/2018

Document Id: 41cff432-7e2d-476b-aa97-34cd86810063

Set id: 33cc1470-f0c2-4e25-bc49-ca23e3b195f0

Version: 6

Effective Time: 20180501

Chattem, Inc.